Automated image-guided tissue resection and treatment

ABSTRACT

A system to treat a patient comprises a user interface that allows a physician to view an image of tissue to be treated in order to develop a treatment plan to resect tissue with a predefined removal profile. The image may comprise a plurality of images, and the planned treatment is shown on the images. The treatment probe may comprise an anchor, and the image shown on the screen may have a reference image marker shown on the screen corresponding to the anchor. The planned tissue removal profile can be displayed and scaled to the image of the target tissue of an organ such as the prostate, and the physician can adjust the treatment profile based on the scaled images to provide a treatment profile in three dimensions. The images shown on the display may comprise segmented images of the patient with treatment plan overlaid on the images.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/846,159, filed on Apr. 10, 2020, which is a continuation of U.S.patent application Ser. No. 15/593,158, filed May 11, 2017, now U.S.Pat. No. 10,653,438, issued May 19, 2020, which is a continuation ofU.S. patent application Ser. No. 14/540,310, filed Nov. 13, 2014, nowU.S. Pat. No. 9,668,764, issued Jun. 6, 2017, which is a continuation ofU.S. patent application Ser. No. 14/334,247, filed Jul. 17, 2014, nowU.S. Pat. No. 9,364,251, issued Jun. 14, 2016, which is a continuationof International Application No. PCT/US2013/028441, filed Feb. 28, 2013,published as WO 2013/130895 on Sep. 6, 2013, which application claimsthe benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication No. 61/604,932, filed Feb. 29, 2012, the entire disclosuresof which are incorporated herein by reference.

The subject matter of this application is related to and incorporates byreference the complete disclosures of the following patents: U.S. patentapplication Ser. No. 12/399,585, filed Mar. 6, 2009, now U.S. Pat. No.8,814,921, issued Aug. 26, 2014, U.S. patent application Ser. No.12/700,568, filed Feb. 4, 2010, now U.S. Pat. No. 9,232,959, issued Jan.12, 2016, and U.S. patent application Ser. No. 11/968,445, now U.S. Pat.No. 7,882,841, issued Feb. 8, 2011.

The subject matter of the present application is also related toInternational Application No. PCT/US2011/023781, filed Apr. 8, 2007,published as WO2011097505 on Nov. 8, 2011, the full disclosure of whichis incorporated herein by reference.

BACKGROUND

The field of the present invention is related to the treatment of tissuewith energy, and more specifically to the treatment of an organ such asthe prostate with fluid stream energy.

Prior methods and apparatus of treating subjects such as patients canresult in less than ideal removal in at least some instances. Forexample, prior methods of prostate surgery can result in longer healingtime and less than desirable outcome than would be ideal in at leastsome instances.

Prior methods and apparatus of imaging tissue can be less than ideal forimaging a treated tissue. For example, prior ultrasound methods andapparatus may not be well suited to view the treatment sight duringtreatment, and alignment of diagnostic images with treatment images canbe less than ideal. Also, at least some of the prior treatment methodsand apparatus of treating tissue may not be well suited from combinationwith imaging systems of the prior art. In at least some instances, itwould be helpful to provide improved imaging of tissue during surgery,for example to provide real time imaging of tissue that would allow auser to adjust the treatment based on real time images of the tissue. Atleast some of the prior methods and apparatus to image tissue duringsurgery can be somewhat cumbersome to use, and can result in delays inthe patient treatment.

Prior methods and apparatus to treat an organ such as the prostate mayprovide a user interface that is somewhat cumbersome for the user, andcan provide less than ideal planning of the surgery. Also, at least someof the prior methods and apparatus to treat tissue such as the prostatetissue can be somewhat less accurate than would be ideal. In at leastsome instances, the prior methods and apparatus may provide a less thanideal user experience. Also, at least some of the prior interfaces mayprovide less than ideal coupling of the treatment apparatus with tissuestructures.

Improved methods for tissue resection are described in U.S. Pat. No.7,882,841 and pending applications U.S. Ser. No. 12/700,568 and U.S.Ser. No. 12/399,585. The methods and systems described in this patentand these patent applications rely on the positioning of a probe such asa uretheral probe, which directs a fluid stream radially outwardly forcontrolled resection of tissue such as the prostate and luminal tissues.Optionally, the fluid stream may be used to deliver light, electrical,heat or other energy sources to aid in resection and/or to cauterize thetreated tissue.

While these methods are very effective and a significant advance overprior luminal tissue treatment protocols, it would be desirable toprovide improvements to assist in more accurate tissue removal in bothfully automated and physician assisted operating modes. At least some ofthese objectives will be met by the inventions described hereinafter.

SUMMARY

Embodiments of the present invention provide improved methods andapparatus for performing tissue resection, such as prostate tissueresection, by positioning an energy source within a urethra. Energy isdirected radially outwardly from the energy source toward tissue thatmay comprise a wall of the urethra within the prostate. The energysource is moved to remove a pre-defined volume of tissue surrounding thelumen, and movement of the energy source is at least partiallycontrolled by an automated controller.

In many embodiments, a user interface is proved that allows a physicianto view an image of tissue to be treated, such prostate tissue. Theimage may comprise a plurality of images, and the planned treatment isshown on a display to the physician. The treatment probe may comprise ananchor, and the image shown on the screen may have a reference imagemaker shown on the screen corresponding to the anchor. The plannedtissue removal profile can be displayed and scaled to the image of thetarget tissue of an organ such as the prostate, and the physician canadjust the treatment profile based on the scaled images. The treatmentprofile can be simultaneously overlaid on a plurality of images of thetissue to be treated. In many embodiments, sagittal and axial views ofthe tissue are displayed, and the treatment profile of the pre-definedvolume shown on the sagittal and axial with a substantially similarscale as the images, such that the treatment can be planned.

In many embodiments, the treatment probe comprises a linkage coupled toan anchor to accurately direct energy to a targeted tissue location. Inmany embodiments, the linkage is fixed to the anchor with a spineextending between the anchor and the linkage to accurately direct energyto the target tissue when the anchor is placed inside the patient. Thetreatment probe may comprise an elongate structure having a workingchannel, and the elongate structure may comprise an elongate elementsuch as a shaft. The elongate structure may comprise the spine to addstiffness and rigidity, and the anchor may be provided on a distal endof the elongate structure. A carrier such as a carrier tube moves withinthe working channel under control of a linkage coupled to a controller.The linkage comprises a first fixed portion to provide a reference frameand a second moving portion to drive the carrier with rotation andtranslation in order to direct energy to the target location when theanchor is fixed to the linkage.

In many embodiments, a coordinate reference system of the treatmentprobe is shown on the display, and the images shown on the display aremapped to the coordinate reference system of the treatment probe, whichmakes it easier for the user to plan the treatment and ensures that thetreatment is properly aligned with the tissue. The treatment probe maycomprise a longitudinal axis, and the image of the tissue and tissuestructures shown on the display can be referenced by the user withrespect to the longitudinal axis treatment coordinate reference system.A radially extending resection distance of the profile may be shown onthe display with reference to a radius extending from the longitudinalaxis, and the radius can vary with an angle around the axis, so as toprovide a pre-define volume having a three dimensional cut profile.

In many embodiments, an energy stream marker is shown on the imagesshown on the display, and the energy stream marker can be moved on thescreen during treatment. The energy stream position can be shown on thesagittal and axial views. The position of the energy stream can varyrotationally along the axial view so as to correspond to sweeping motionof the energy stream around the longitudinal axis of the probe, and thelongitudinal position of the energy stream can move along the sagittalimage of the tissue and treatment profile so as to indicate the locationof the energy stream along the longitudinal axis of the treatment. Theimages of the moving energy stream shown on the display can be shown inreal time, so as to give the user an indication of the progress andcompleteness of the treatment.

The images of the tissue shown on the display may comprise useridentifiable tissue structures, and may comprise tissue of an organhaving an identifiable tissue structure of an organ such as theprostate. The image of the target tissue shown on the display maycomprise one or more of an anatomical representation of the tissue to betreated, an image of the patient to be treated, a pre-operative image ofthe tissue to be treated, or a real-time image of the tissue of thepatient when the patient is treated. The image of the target tissueshown on the display comprises structure of the target tissue, and maycomprise an image of an organ containing the target tissue.

In many embodiments, a three dimensional data of the target tissue ofthe patient is obtained, and may be displayed to the user as a threedimensional representation. The three dimensional data may be shown insagittal and axial cross sections, and the cross-sections may comprisesegmentation of the targeted tissue. The three dimensional data can beobtained in one or more of many ways, and may comprise ultrasound data,magnetic resonance imaging data, positron emission tomography data, orcomputerized axial tomography data. In many embodiments, threedimensional data of the prostate are obtained, and segmented imagesalong sagittal and transverse planes are displayed to the user.

The images of the patient shown on the display can be aligned mapped tothe treatment coordinate reference system, and the mapped treatmentprofile shown on the patient images. The images of the patient maycomprise one or more structures of the probe inserted into the patient,and the structures of the probe in the image can be identified in orderto align the image with the markers of the treatment plan shown on thedisplay. The identified structure of the image of the patient maycomprise an anchoring balloon in an expanded configuration, and theballoon can be aligned with an anchor reference marker of the treatmentplan.

Additional reference markers may be provided on the images to allowtreatment planning, and in many embodiments, these reference markers canbe verified prior to treatment. Additional structures of the patientimage can be identified and aligned with the additional referencemarkers of the treatment plan in order to align the patient image withthe treatment plan. The patient image can be mapped to the treatmentprobe coordinate reference system. Alternatively or in combination, thetreatment plan comprising the treatment profile and pre-definedtreatment volume can be mapped from the treatment probe coordinatereference system to the patient image coordinate reference systemprovided by an imaging probe.

In many embodiments, the treatment probe and imaging probe are coupledin order to provide accurate alignment of the treatment probe andimaging probe. The treatment probe and imaging probe can be coupled inmany ways. In many embodiments the treatment probe and imaging probe arecoupled with a common base. Alternatively or in combination, magnets canbe provided to couple the imaging probe to the treatment probe. A firstarm can extend from the base to the elongate treatment probe, and asecond arm can extend from the base to the elongate imaging probe. Thefirst arm and the second arm may each comprise a first movableconfiguration in which the arm can be moved to insert the probe into thepatient and a second locked configuration in which movement of the armis inhibited. The second arm may comprise actuators to allow finemovement and positioning of the imaging probe in order to align theimaging probe with the treatment probe and target tissue.

In many embodiments, angle sensors are provided to determine an angularorientation of one or more of the imaging probe of the treatment probe.Each angle sensor can be connected to the probe, for example fixed tothe probe, such that the angle sensor can be used to determine anorientation of the elongate axis of the probe and rotation of the probearound the elongate axis. Each angular sensor may comprise one or moreof a goniometer or an accelerometer, and may comprise a threedimensional angle sensor such as a three dimensional accelerometer.

The treatment probe and the imaging probe can be inserted into thepatient in one or more of many ways. In many embodiments, the imagingprobe is inserted into a first side of the patient and the treatmentprobe is inserted into a second side of the patient. The imaging probemay comprise a trans-rectal ultrasound probe inserted from a posteriorside of the patient and the treatment probe is inserted into the urethraof the patient from an anterior side of the patient.

In many embodiments, the treatment probe is configured to image thetarget tissue. The treatment probe comprises an elongate structurehaving a working channel sized to receive an endoscope and a carrier ofa carrier tube, and the carrier is configured to direct and scan a lightbeam on the treatment area to determine a profile of the tissue removed,and carrier may be configured to release a fluid stream comprising awaveguide and scan the light pattern the fluid stream comprising thewaveguide. The profile of removed tissue can be determined based onlocations of the light beam from endoscope images. Alternatively or incombination, the carrier may comprise at least one acoustic transducerto measure the location of remaining tissue and provide a tissueresection profile. The longitudinal location of the carrier and angularorientation of the carrier can be determined based on controllercommands to the linkage used to position the carrier in relation to theanchor.

In many embodiments, a manifold is connected to a proximal end of theelongate structure, and a coupling joint is provided between the linkageand the manifold to allow the linkage to be decoupled from the patientwhen the elongate structure and anchor remain placed in the patient. Themanifold comprises a plurality of ports and a plurality of channels thatare coupled to the treatment site, for one or more of flushing,insufflation, or inflation of the anchoring balloon. The manifold thatremains connected to the elongate structure having the working channelwhen the linkage is not connected has many advantages. The elongatestructure can be configured in many ways, and the elongate structure maycomprise an elongate tubular shaft structure that defines a workingchannel, a plurality of channels and a sheath. The working channel, theplurality of channels and the sheath of the elongate structure mayextend from the manifold to the working site. In many embodiments, theelongate structure comprises a stiff element to add stiffness andrigidity, such as a spine extending from the manifold to the anchor andthe spine may comprise a stiff or rigid tubular member. The manifoldallows fluid delivery to the treatment site with the elongate structurewith the one or more fluid delivery channels and a sheath extendingaround the spine. The surgical site can be accessed with surgical toolsand imaging apparatus such as an endoscope when the anchor comprises anexpanded configuration. The elongate structure can be advanced to thetreatment site and the anchor expanded prior to coupling the linkage tothe elongate structure.

In a first aspect, embodiments provide method for tissue resection. Themethod comprises positioning an energy source within tissue. Energy isdirected radially outwardly from the energy source toward the tissue.The energy source is moved to remove a pre-defined volume of tissue,wherein movement of the energy source is at least partially controlledby an automated controller

In another aspect, embodiments provide a method for tissue resection ofan organ such as the prostate. An energy source is positioned within aurethra having a lumen. Energy is directed radially outwardly from theenergy source toward a wall of the urethra within the prostate. Theenergy source is moved to remove a pre-defined volume of tissuesurrounding the lumen, wherein movement of the energy source is at leastpartially controlled by an automated controller.

In many embodiments, the automated controller controls movement of theenergy source based on a predetermined plan.

In many embodiments, the automated controller controls movement of theenergy source based on a predetermined plan.

In many embodiments, the predetermined plan is input by a user based onpre-operative images of the prostate.

In many embodiments, the automated controller controls movement of theenergy source based on real time assessment of the prostate.

In many embodiments, the real time assessment comprises interstitial,laser guided imaging.

In many embodiments, the real time assessment comprises acousticdistance measurement.

In many embodiments, the real time assessment comprises interstitialsound guided differentiation.

In many embodiments, the automated control further comprises pulse widthmodulation.

In many embodiments, a user overrides the automated control.

In many embodiments, an image of a prostate is provided on a displaycoupled to a processor, the display capable of being viewed by a user. Aplurality of input parameters is received corresponding to an axiallength and a radial distance of the pre-defined volume of tissue. Apredefined tissue removal profile of the predefined volume is shown onthe image of the prostate on the display based on the plurality of inputparameters.

In many embodiments, the plurality of input parameters comprises one ormore of a longitudinal distance of the removal profile, a radialdistance of the removal profile, an angular distance of the removalprofile around a longitudinal axis of the removal profile, an axis ofthe removal profile, a central location of the removal profile, or auser defined input removal profile in response to the user moving apointer over the image of the prostate.

In many embodiments, the image of the prostate comprises an axial viewof the prostate and a sagittal view of the prostate, and an axial viewof the predefined tissue removal profile is shown on the axial view ofthe prostate and sagittal view of the tissue removal profile is shown onthe sagittal view of the prostate.

In many embodiments, the axial view of the predefined removal profile isadjusted based on the radial distance and the angular distance of thepredefined removal profile, and the axial view of the predefined removalprofile is adjusted based on the axial distance and the radial distanceof the predefined removal profile.

In many embodiments, the tissue removal profile shown on the image ofthe prostate comprises dimensions scaled to the image of the prostateshown on the display such that dimensions of the tissue removal profileshown on the display correspond to dimensions of the image of theprostate shown on the display.

In many embodiments, a treatment reference marker is shown with theimage of the prostate and wherein the tissue removal profile is shown onthe display in relation to the treatment reference marker based on theplurality of input parameters.

In many embodiments, the treatment reference marker shown on the displaycorresponds to an anchor connected to the energy source.

In many embodiments, the treatment reference marker shown on the displaycorresponds to an expandable anchor connected to the energy source andwherein the expandable anchor comprises a first narrow profileconfiguration sized for insertion into the lumen and a second wideprofile configuration to inhibit passage through the lumen when placedin a neck of a bladder of the patient and wherein the treatmentreference marker shown on the display comprises an image of anexpandable anchor in a wide profile configuration on a superior end ofthe image of the prostate.

In many embodiments, the image of the prostate shown on the displaycomprises an image of the prostate of the patient or an anatomicalrepresentation of a prostate suitable for use with a plurality ofpatients.

In many embodiments, the image of the image of the prostate of thepatient shown on the display comprises a transrectal ultrasound image ofthe prostate of the patient.

In many embodiments, a nozzle is identified among a plurality of nozzlesto treat the patient with a pressurized fluid stream based on a radialdistance of the tissue removal profile input into the processor.

In many embodiments, the tissue is coagulated with a light beam at aradial distance and an angular distance of a portion of the tissueremoval profile subsequent to removal of the tissue with the pressurizedfluid steam and wherein the angular distance corresponds to a posteriorportion of the removal profile.

In many embodiments, the fluid stream comprises a divergent stream of asubstantially incompressible fluid and wherein the light beam comprisesa divergent light beam.

In many embodiments, a treatment axis of the pre-defined treatmentvolume is aligned with an axis of the patient based on an image of theprostate and energy emitted radially from the probe.

In many embodiments, the axis of the pre-defined volume comprises ananterior-posterior axis of the treatment volume, and theanterior-posterior axis of the treatment volume is aligned with ananterior posterior direction of the patient based on visualization ofthe tissue and an angle of energy emitted radially from the probe inorder to rotationally align the treatment energy emitted from the probewith the anterior-posterior direction of the patient.

In many embodiments, the image comprises an ultrasound image showing oneor more of deflection of the tissue or a fluid stream in response topressurized fluid released from a nozzle, and an angle of the fluidstream around an elongate axis of a treatment probe is adjusted to alignthe treatment axis with the axis of the patient.

In many embodiments, the image comprises an optical image showing alight beam emitted radially from the probe illuminating the tissue andwherein an angle of the light beam around an elongate axis of thetreatment probe is adjusted to align the treatment axis with thepatient.

Many embodiments further comprises a processor, and the processorcomprises instructions for the user to adjust an angle of the energyradially emitted from the treatment probe around an elongate axis of thetreatment probe to align the energy radially emitted with an axis of thepatient, and the processor comprises instructions to input the angle inresponse to a user command when the angle of the energy is aligned withthe axis of the patient, and the processor comprises instructions torotate the treatment axis based on the angle input into the processor.

In many embodiments, an angular rotation sensor determines a rotation ofthe treatment probe around an elongate axis of the probe in relation toan axis of the patient, and a treatment axis of the pre-definedtreatment volume is rotated in response to the rotation of the treatmentprobe and wherein the patient is placed on a patient support such thatan anterior posterior direction of the patient is aligned with adirection of gravitational pull.

In many embodiments, the angular rotation sensor comprises one or moreof an accelerometer or a goniometer.

In another aspect, embodiments provide a tissue resection. A carrier hasa proximal end and a distal end. At least one energy source on thecarrier is spaced proximally to be positioned in the tissue when fordelivering energy radially outwardly. An automated controller controlsmovement of the at least one energy source to effect volumetric tissueremoval.

In another aspect, embodiments provide a tissue resection apparatus toresect tissue of an organ such as the prostate. The apparatus comprisesa carrier having a proximal end and a distal end. At least one energysource on the carrier is spaced proximally to be positioned in theurethra when for delivering energy radially outwardly. An automatedcontroller controls movement of the at least one energy source to effectvolumetric tissue removal.

In many embodiments, the automated controller controls movement of theenergy source based on a predetermined plan.

In many embodiments, the predetermined plan is input by a user based onpre-operative images of the prostate.

In many embodiments, the automated controller controls movement of theenergy source based on real time assessment of the prostate obtainedfrom an input device.

In many embodiments, the input device comprises an interstitial, laserguided imaging device.

In many embodiments, the input device comprises an interstitial, laserguided imaging device.

In many embodiments, the input device comprises an interstitial soundguided differentiation detector.

In many embodiments, the automated controller further comprises a pulsewidth modulation device.

Many embodiments further comprise means for the user to override theautomated controller.

Many embodiments further comprise a processor comprising instructionsconfigured:

-   -   to provide an image of a prostate on a display visible to a        user; and    -   to receive a plurality of input parameters corresponding to an        axial length and a radial distance of the pre-defined volume of        tissue;    -   wherein a predefined tissue removal profile of the predefined        volume is shown on the image of the prostate on the display        based on the plurality of input parameters.

In many embodiments, the plurality of input parameters comprises one ormore of a longitudinal distance of the removal profile, a radialdistance of the removal profile, an angular distance of the removalprofile around a longitudinal axis of the removal profile, an axis ofthe removal profile, a central location of the removal profile, or auser defined input removal profile in response to the user moving apointer over the image of the prostate.

In many embodiments, the image of the prostate comprises an axial viewof the prostate and a sagittal view of the prostate, and wherein anaxial view of the predefined tissue removal profile is shown on theaxial view of the prostate and sagittal view of the tissue removalprofile is shown on the sagittal view of the prostate.

In many embodiments, the processor comprises instructions to adjust theaxial view of the predefined removal profile based on the radialdistance and the angular distance of the predefined removal profile andwherein the processor comprises instructions to adjust the axial view ofthe predefined removal profile based on the axial distance and theradial distance of the predefined removal profile.

In many embodiments, the tissue removal profile shown on the image ofthe prostate comprise dimensions scaled to the image of the prostateshown on the display such that dimensions of the tissue removal profileshown on the display correspond to dimensions of the image of theprostate shown on the display.

In many embodiments, the processor comprises instructions to show atreatment reference marker with the image of the prostate and to showthe tissue removal profile on the display in relation to the treatmentreference marker based on the plurality of input parameters.

In many embodiments, the treatment reference marker shown on the displaycorresponds to an anchor connected to the energy source.

In many embodiments, the treatment reference marker shown on the displaycorresponds to an expandable anchor connected to the energy source andwherein the expandable anchor comprises a first narrow profileconfiguration sized for insertion into the lumen and a second wideprofile configuration to inhibit passage through the lumen when placedin a neck of a bladder of the patient and wherein the treatmentreference marker shown on the display comprises an image of anexpandable anchor in a wide profile configuration on a superior end of asagittal image of the prostate.

In many embodiments, the treatment reference marker shown on the displaycomprises a fixed reference marker, and the processor comprisesinstructions to show a movable marker that moves in relation to thefixed reference marker and the treatment profile to show a location ofan energy stream to a target tissue in real time.

In many embodiments, the movable marker is shown a plurality of images,the plurality of images comprising a sagittal image along a sagittalaxis of treatment and an axial image transverse to the axis oftreatment, and wherein the movable marker moves along the axis oftreatment in the sagittal image and the movable marker rotates aroundthe axis in the axial image and wherein the fixed reference marker isdisplayed on each of the plurality of images in relation to the movablemarker.

In many embodiments, the image of the prostate shown on the displaycomprises an image of the prostate of the patient or an anatomicalrepresentation of a prostate suitable for use with a plurality ofpatients.

In many embodiments, the image of the image of the prostate of thepatient shown on the display comprises a transrectal ultrasound image ofthe prostate of the patient.

In many embodiments, the processor comprises instructions to identify anozzle among a plurality of nozzles to treat the patient with apressurized fluid stream based on a radial distance of the tissueremoval profile input into the processor.

In many embodiments, the processor comprises instructions to coagulatetissue with a light beam at a radial distance and an angular distance ofa portion of the tissue removal profile subsequent to removal of thetissue with the pressurized fluid steam and wherein the angular distancecorresponds to a posterior portion of the removal profile.

In many embodiments, the fluid stream comprises a divergent stream of asubstantially incompressible fluid and wherein the light beam comprisesa divergent light beam.

In many embodiments, a treatment axis of the pre-defined treatmentvolume is aligned with an axis of the patient based on an image of theprostate and energy emitted radially from the probe.

In many embodiments, the axis of the pre-defined volume comprises ananterior-posterior axis of the treatment volume and wherein theanterior-posterior axis of the treatment volume is aligned with ananterior posterior direction of the patient based on visualization ofthe tissue and an angle of energy emitted radially from the probe inorder to rotationally align the treatment energy emitted from the probewith the anterior-posterior direction of the patient.

In many embodiments, the image comprises an ultrasound image showing oneor more of deflection of the tissue or a fluid stream in response topressurized fluid released from a nozzle and wherein an angle of thefluid stream around an elongate axis of a treatment probe is adjusted toalign the treatment axis with the axis of the patient.

In many embodiments, image comprises an optical image showing a lightbeam emitted radially from the probe illuminating the tissue and whereinan angle of the light beam around an elongate axis of the treatmentprobe is adjusted to align the treatment axis with the patient.

Many embodiments further comprise a processor and wherein the processorcomprises instructions for the user to adjust an angle of the energyradially emitted from the treatment probe around an elongate axis of thetreatment probe to align the energy radially emitted with an axis of thepatient and wherein the processor comprises instructions to input theangle in response to a user command when the angle of the energy isaligned with the axis of the patient and wherein the processor comprisesinstructions to rotate the treatment axis based on the angle input intothe processor.

In many embodiments, an angular rotation sensor determines a rotation ofthe treatment probe around an elongate axis of the probe in relation toan axis of the patient and wherein a treatment axis of the pre-definedtreatment volume is rotated in response to the rotation of the treatmentprobe and wherein the patient is placed on a patient support such thatan anterior posterior direction of the patient is aligned with adirection of gravitational pull.

In many embodiments, the angular rotation sensor comprises one or moreof an accelerometer or a goniometer.

Many embodiments further comprise a processor comprising instructionsconfigured:

-   -   to provide a plurality of images of a tissue on a display        visible to a user, each image of the plurality comprising a        plane of a three dimensional representation of the tissue;    -   to receive input from the user to define a treatment profile        along said each image of the plurality of images; and    -   to determine a three-dimensional treatment profile based on the        treatment profile along said each of the plurality of images.

In many embodiments, the processor comprises instructions to interpolateamong treatment profiles of the plurality of images to determine thethree-dimensional treatment profile.

Many embodiments further comprise a non-pulsatile pump coupled to thecarrier and the automated controller to provide a pulsed energy streamcomprising a plurality of sequential pulses.

Many embodiments further comprise a pulsatile pump coupled to thecarrier and the automated controller to provide a pulsed energy streamcomprising a plurality of sequential pulses.

In many embodiments, the automated controller is configured to move thepulsed energy delivery stream such that the plurality of sequentialpulses overlap at a target location of tissue to be removed.

In many embodiments, the automated controller is configured to move thepulsed energy delivery stream such that the plurality of sequentialpulses do not overlap at a target location of tissue to be removed.

In another aspect, embodiments provide an apparatus to treat tissue of apatient. An elongate treatment probe to treat a patient extends along anaxis. The elongate treatment probe comprises an outer elongate structurehaving a working channel and an inner carrier rotatable and translatablewithin the working channel to position and orient an energy source torelease energy toward a target tissue. An elongate imaging probe, theelongate imaging probe extends along an axis. A coupling couples theelongate treatment probe to the elongate imaging probe when the elongatetreatment probe and the elongate imaging probe have been inserted intothe patient.

Many embodiments further comprise a first linkage connected to the innercarrier and a second linkage connected to the imaging probe, wherein oneor more controllers is configured to move the first linkage togetherwith the second linkage to move the inner carrier along a treatment axisand move the imaging probe along an imaging probe axis in order to viewinteraction of the carrier with tissue as the carrier moves along theaxis.

In many embodiments, the coupling comprises:

a base;

a first arm extending from the base and connected to a proximal end ofthe elongate treatment probe; and

a second arm extending from the base and connected to a proximal end ofthe elongate imaging probe;

wherein the base supports the elongate treatment probe and the elongateimaging probe when the first arm comprises a stiff configuration and thesecond arm comprises a stiff configuration.

In many embodiments, the second arm comprises an actuator to manipulatethe imaging probe under user control when the first arm maintains aposition and orientation of the elongate treatment probe.

In many embodiments, the coupling is configured to maintain alignment ofthe elongate treatment probe in relation to the elongate imaging probewhen the elongate imaging probe and the elongate treatment probe havebeen inserted from opposite sides of the patient.

In many embodiments, the coupling is configured to maintain an alignmentof the axis of the elongate treatment probe with the axis of theelongate imaging probe when the nozzle is advanced proximally anddistally and rotated.

In many embodiments, the coupling is configured to align the axis of thetreatment probe parallel with the axis of the imaging probe.

In many embodiments, the coupling is configured to maintain a fixedposition and orientation of the elongate imaging probe in relation tothe elongate imaging probe.

In many embodiments, the coupling comprises a stiff arm coupled to theelongate treatment probe and a second stiff arm coupled to the elongateimaging probe, the first stiff arm fixedly coupled to the second stiffarm, and wherein the elongate treatment probe comprises stiffness toinhibit deflection transverse to the treatment probe axis and theelongate imaging probe comprises stiffness to inhibit deflectiontransverse to the elongate imaging probe axis.

In many embodiments, the coupling comprises magnets to maintain a fixedposition and orientation of the elongate imaging probe in relation tothe elongate imaging probe.

In many embodiments, the coupling comprises a plurality of magnetsarranged at a plurality of axial locations along one or more of theelongate treatment probe or the elongate imaging probe.

In many embodiments, the coupling is configured to couple the elongatetreatment probe to the elongate imaging probe through a wall of a firstlumen extending over a portion of the elongate treatment probe and awall of a second lumen extending over a portion of the elongate imagingprobe.

In many embodiments, the elongate imaging probe is configured forinsertion into a rectum of the patient and the elongate treatment probeis configured for insertion into a urethra of the patient and whereinthe coupling is configured to align the elongate treatment probe withthe elongate imaging probe when the elongate treatment probe is placedwithin the urethra and the elongate imaging probe is placed within therectum.

In many embodiments, the elongate structure comprises a spine to addstiffness to the probe such that the elongate structure inhibitsdeflection of the probe transverse to the axis.

In many embodiments, the elongate imaging probe comprises at least astiff distal portion to inhibit deflection of the imaging probetransverse to the axis of the imaging probe and to fix the orientationof the axis of the elongate imaging probe in relation to the axis of theelongate treatment probe.

In many embodiments, a processor is coupled to the elongate imagingprobe, the elongate treatment probe and the linkage and wherein theprocessor comprises instructions to determine a pressure, an axiallocation and an orientation of the nozzle to ablate a target location ofthe tissue identified on an image of the elongate imaging probe.

In many embodiments, the processor comprises instructions to determinethe pressure, the axial location and orientation of the nozzle inresponse to the target location on the image when the elongate treatmentprobe has been inserted on a first side of the patient and the elongateimaging probe has been inserted on a second side of the patient oppositethe first side.

In many embodiments, the processor comprises instructions to determinethe pressure, the axial location and orientation of the nozzle inresponse to the target location on the image when the elongate treatmentprobe has been coupled to the elongate imaging probe through a wall of afirst lumen and a wall of a second lumen extending between the elongatetreatment probe and the elongate imaging probe.

In many embodiments, the processor comprises instructions to determine afirst image coordinate reference of a first input target location of theimage and a second image coordinate reference of a second input targetlocation of the image and instructions to map the first image coordinatereference of the image to a first target coordinate reference of thetreatment probe and to map the second input target location of the imageto a second target coordinate reference of the treatment probe andwherein the processor comprises instructions to determine pressures andaxial and rotational positions of the nozzle to provide a cut profileextending from the first input target location to the second inputtarget location.

In another aspect, embodiments provide an apparatus to treat tissue of apatient. An arm is coupled to a base. The arm comprises a first movableconfiguration and a second stiff configuration. A treatment probe totreat a patient comprises an outer elongate structure having a workingchannel and an inner carrier rotatable and translatable within theworking channel to position and orient a nozzle to release a pressurizedstream of fluid toward the tissue. A processor comprises instructions torotate and translate the carrier to treat the patient. A linkage iscoupled to the processor and the probe to rotate and translate the probein response to the instructions.

In many embodiments, the carrier comprises a rapid exchange carrierconfigured to be inserted and removed from a proximal end of the outerelongate structure and wherein the linkage comprises a rotatable andtranslatable elongate linkage tube having an inner dimension sized toreceive the inner carrier and wherein the elongate linkage tubecomprises a locking structure to lock the rapid exchange carrier withinthe elongate linkage tube when the elongate linkage tube rotates andtranslates to treat tissue.

Many embodiments further comprise a manifold and a plurality ofchannels, the manifold connected to a proximal end of the outer elongatestructure, the plurality of channels extending along the outer elongatestructure to couple a first port of the manifold to a balloon anchorwith a first channel and to couple a second port of the manifold with anopening near a distal end of the outer elongate fluid to deliver fluidto a treatment site and wherein the manifold comprises a lockingstructure and the linkage comprises a locking structure to connect thelinkage to the manifold when the balloon has been inflated.

In many embodiments, the elongate structure comprises a spine coupled toan anchor, and wherein the spine extends between the anchor and thelinkage to fix a distance from a first portion of the linkage to theanchor when the probe the carrier is rotated and translated with asecond portion of the linkage to position and orient the nozzle to treata target location of the patient referenced to the anchor.

In many embodiments, the elongate structure comprises is coupled to ananchor, and wherein the elongate structure extends between the anchorand the linkage to fix a distance along the elongate structure from afirst portion of the linkage to the anchor when the carrier is rotatedand translated with a second portion of the linkage to position andorient the nozzle to treat the patient.

In many embodiments, the elongate structure and the carrier areconfigured to deflect as the probe is inserted into the tissue andwherein the elongate structure maintains a substantially constant arclength between a fixed portion of the linkage and the anchor in order tomaintain placement of the nozzle in relation to the anchor when nozzleis rotated and translated along the probe axis with the carrier to treatthe patient.

In many embodiments, the linkage comprises an outer hand piece portiongraspable and positionable with a hand of the user when the armcomprises an unlocked configuration.

In many embodiments, the linkage comprises a support coupled to thetreatment probe and the arm to support the treatment probe and thelinkage with the arm when the probe has been inserted into the patient.

In many embodiments, the support comprises one or more of a rigid casingof the linkage or a frame of the linkage and wherein the casing remainssubstantially fixed with the arm when the patient is treated.

In many embodiments, the support is coupled to the treatment probe toinsert the probe in the patient and position the nozzle at a targetlocation and orientation and wherein the support is coupled to the armand the elongate structure in order to support the probe with the probepositioned and oriented within the patient when the arm comprises thestiff configuration.

In many embodiments, the support and arm are capable of supporting thelinkage and the probe at an intended position and orientation when thearm comprises the stiff configuration in order to fix the location ofthe linkage when the patient is treated with the nozzle.

In many embodiments, the probe comprises an elongate structure and aninner carrier and wherein the linkage is coupled to the carrier tocontrol a position the nozzle along an axis of the elongate structureand a rotation of the nozzle around the axis of the elongate structure.

In many embodiments, the apparatus is configured to remove living cellsof the tissue in order to provide the living cells outside the patient.

In many embodiments, the apparatus is configured to remove tissue forhistology.

In many embodiments, the apparatus is configured to macerate the tissue.

In many embodiments, the apparatus is configured to release a highpressure fluid stream into a gas comprising carbon dioxide (hereinafter“CO2”).

In many embodiments, the apparatus comprises an optical fiber havingbend radius of no more than about 5 mm.

In many embodiments, the apparatus comprises an optical fiber having abend radius of no more than about 2 mm.

While embodiments of the present invention are specifically directed attransurethral treatment of the prostate, certain aspects of theinvention may also be used to treat and modify other organs such asbrain, heart, lungs, intestines, eyes, skin, kidney, liver, pancreas,stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, softtissues such as bone marrow, adipose tissue, muscle, glandular andmucosal tissue, spinal and nerve tissue, cartilage, hard biologicaltissues such as teeth, bone, as well as body lumens and passages such asthe sinuses, ureter, colon, esophagus, lung passages, blood vessels, andthroat. The devices disclosed herein may be inserted through an existingbody lumen, or inserted through an opening created in body tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of the disclosure are utilized, and the accompanying drawingsof which:

FIG. 1 is a schematic illustration of a device suitable for performingintraurethral prostatic tissue debulking in accordance with theprinciples of the present invention;

FIGS. 2A-2D illustrate use of the device of FIG. 1 in performingprostatic tissue debulking;

FIG. 3 illustrates a specific prostatic tissue treatment deviceincorporating the use of a radiofrequency saline plasma for performingprostatic tissue debulking;

FIG. 4 illustrates an energy source suitable for use in the devices ofthe present invention, wherein the energy source delivers a fluid streamfor tissue resection;

FIG. 5 illustrates an energy source suitable for use in devices of thepresent invention, wherein the energy source comprises a deflectedoptical waveguide for delivering laser energy to the prostatic tissue;

FIG. 6 illustrates a device similar to that shown in FIG. 5, except theoptical waveguide directs laser energy at a mirror which laterallydeflects the laser energy;

FIG. 7 illustrates an energy source suitable for use in the devices ofthe present invention, wherein the energy source comprises a laterallyprojecting electrode which can engage the urethral wall and prostatictissue to deliver radiofrequency energy for tissue ablation;

FIG. 8 is a graph of tissue resection rates demonstrating criticalpressures;

FIG. 9a is a flow diagram illustrating selective and controlledresection;

FIG. 9b is a flow diagram illustrating selective resection, wherein thefluid stream is configured to penetrate the urethral wall beforeresecting the prostate tissue;

FIG. 10a illustrates a columnar fluid stream and a diverging fluidstream;

FIG. 10b illustrates a cross-sectional view of a tissue modificationdevice configured to emit a columnar fluid stream;

FIG. 10c illustrates a cross-sectional view of a tissue modificationdevice configured to emit a diverging fluid stream;

FIG. 11 illustrates a tissue modification device that uses a fluidstream for tissue resection, wherein the fluid stream may optionally actas a conduit for electromagnetic energy;

FIG. 12 shows a component of treatment probe 350 in accordance withembodiments;

FIGS. 13A and 13B show a system that treat a patient in accordance withembodiments;

FIG. 14A shows a multipurpose sheath and manifold in accordance withembodiments;

FIG. 14B shows manifold conduits of the manifold as in FIG. 14Aconfigured for transmit and reception of multiple fluids while themanifold remains coupled to the patient in accordance with embodiments;

FIG. 14C shows components of treatment probe and linkage in accordancewith embodiments;

FIG. 14D1 shows rapid exchange of a carrier when the linkage is coupledto the elongate element anchored to a target location of an organ, inaccordance with embodiments;

FIG. 14D2 shows alignment of the distal tip of the carrier with theproximal end of the linkage to insert the carrier tube as in FIG. 14D1;

FIG. 14D3 shows the carrier advanced toward a locking structure on theproximal end of the linkage as in FIG. 14D1;

FIG. 14D4 shows the carrier locked to the linkage as in FIGS. 14D1 and14D2;

FIG. 14E shows a cytoscope inserted at least partially into an elongateelement for advancement toward a bladder neck to view tissue of an organsuch as the prostate, in accordance with embodiments;

FIG. 14F shows advancement of an elongate element into a sheath;

FIG. 14G shows a linkage coupled to an elongate element comprising aspine in accordance with embodiments;

FIG. 14H shows a carrier tube and carrier inserted into the linkage tubein accordance with embodiments;

FIGS. 15 and 16 show self cleaning with a fluid jet in accordance withembodiments;

FIG. 17A shows components of user interface on the display of thepatient treatment system as in FIG. 13 in accordance with embodiments;

FIGS. 17B and 17C show a marker moving on a plurality of images in whichmovement of the marker corresponds to the position and orientation of anenergy stream in accordance with embodiments;

FIG. 17D shows a user defined cut profile in accordance withembodiments;

FIGS. 17E and 17F show a user interface to define a plurality of curvedportions of a cut profile in accordance with embodiments;

FIG. 18 shows a system configuration mode for the cutting mode input ofthe user interface as in FIG. 17A;

FIG. 19 shows a coagulation mode selected with input of the userinterface as in FIG. 17A;

FIG. 20A shows mapping and alignment of an image of the patient with thetreatment coordinate reference frame in accordance with embodiments;

FIG. 20B shows a method of treating a patient in accordance withembodiments;

FIGS. 21A and 21B show screenshots of a 3d segmentation image used inaccordance with the systems and methods of embodiments;

FIGS. 21C to 21F show a plurality of axial images of a target tissue todefine a three dimensional treatment plan and a user defined treatmentprofile in each of the plurality of images;

FIG. 21G shows a sagittal view of the target tissue and planes of theaxial images of FIGS. 21C to 21F;

FIG. 21H shows a three dimensional treatment plan based on the pluralityof images of FIGS. 21A to 21F;

FIG. 21I shows a user input treatment profile of an image among aplurality of images;

FIG. 21J shows scan patterns of the fluid stream, in accordance withembodiments;

FIG. 21K shows a bag over a fluid stream comprising a water hammer inaccordance with embodiments;

FIGS. 22A and 22B show schematic illustrations of a probe being operatedin accordance with the principles of embodiments;

FIG. 22C shows an endoscope placed in the working channel of elongateelement with carrier to image tissue when the patient is treated inaccordance with embodiments;

FIGS. 23A and 23B show a carrier configured to provide integrated jetdelivery in accordance with embodiments;

FIG. 24 shows carrier comprising a fluid delivery element and designconsiderations of the fluid delivery element, in accordance withembodiments;

FIGS. 25A through 25C show jet deflection in accordance withembodiments;

FIGS. 26A through 26C show jet masking in accordance with embodiments;

FIGS. 27A and 27B show variation of jet angle in accordance withembodiments;

FIG. 28 shows multiple jets delivered simultaneously in accordance withembodiments;

FIG. 29 shows morcellation in accordance with embodiments;

FIGS. 30 to 31B shows single tube designs in accordance withembodiments;

FIG. 32 shows means of registering and locating the treatment systemwith respect to the human anatomy in accordance with embodiments;

FIG. 33 shows a plurality of expandable structures comprising a firstexpandable basket and a second expandable basket in accordance withembodiments;

FIG. 34 shows means of registering the system with respect to the humananatomy in accordance with embodiments;

FIG. 35 shows a disposable balloon in accordance with embodiments;

FIG. 36 shows tissue resection and depth control in accordance withembodiments;

FIG. 37 shows the visible entrainment region at a first size as is shownin FIG. 36;

FIG. 38 shows tissue resection depth control in accordance withembodiments;

FIG. 39 shows an optical image of the entrainment region “flame” insaline as shown in FIG. 38 with a different pressure than is shown inFIGS. 36 and 37, in accordance with embodiments;

FIG. 40 shows nozzle flow rate versus maximum penetration depth for aplurality of pressures and nozzles in accordance with embodiments;

FIG. 41 shows nozzle back pressure versus maximum depth of penetrationin accordance with embodiments; and

FIG. 42 shows nozzle flow rate versus back pressure for 130 micronnozzle and 150 micron nozzle in accordance with embodiments.

FIG. 43 is a schematic illustration of a device suitable for performingintraurethral prostatic tissue debulking in accordance with theprinciples of the present invention.

FIGS. 44A-44E illustrate an alternative design for the tissue debulkingdevice of the present invention, illustrating specific components andfeatures for delivering fluids, inflating balloons, rotating andreciprocating the fluid and light delivery mechanism, and the like.

FIG. 45 illustrates a robotically deployed pressurized fluid/coherentlight delivery mechanism.

FIG. 46 illustrates a system for deploying a tissue debulking devicesimilar to that illustrated in FIGS. 44A-44E and including a tissuestabilization sheath and schematically illustrating the various drivemechanisms in accordance with the principles of the present invention.

FIG. 47 is a schematic illustration of a device constructed inaccordance with the present invention suitable for performing tissuecutting or other procedures where an axial pressurized liquid stream isdelivered from a distal tip of the device and carries focused coherentlight from a waveguide.

FIG. 48 illustrates use of the device of FIG. 47 as a scalpel forcutting tissue.

DETAILED DESCRIPTION

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of embodiments of the invention are utilized, and theaccompanying drawings.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the invention but merely asillustrating different examples and aspects of the invention. It shouldbe appreciated that the scope of the invention includes otherembodiments not discussed in detail above. Various other modifications,changes and variations which will be apparent to those skilled in theart may be made in the arrangement, operation and details of the methodand apparatus of the present invention disclosed herein withoutdeparting from the spirit and scope of the invention as describedherein.

The embodiments disclosed herein can be combined in one or more of manyways to provide improved therapy to a patient. The disclosed embodimentscan be combined with prior methods and apparatus to provide improvedtreatment, such as combination with known methods of prostate surgeryand surgery of other tissues and organs, for example. It is to beunderstood that any one or more of the structures and steps as describedherein can be combined with any one or more additional structures andsteps of the methods and apparatus as described herein, the drawings andsupporting text provide descriptions in accordance with embodiments.

Although the treatment planning and definition of treatment profiles andvolumes as described herein are presented in the context of prostatesurgery, the methods and apparatus as described herein can be used totreat any tissue of the body and any organ and vessel of the body suchas brain, heart, lungs, intestines, eyes, skin, kidney, liver, pancreas,stomach, uterus, ovaries, testicles, bladder, ear, nose, mouth, softtissues such as bone marrow, adipose tissue, muscle, glandular andmucosal tissue, spinal and nerve tissue, cartilage, hard biologicaltissues such as teeth, bone, etc. as well as body lumens and passagessuch as the sinuses, ureter, colon, esophagus, lung passages, bloodvessels and throat.

The imaging and treatment probes as described herein can be combined inone or more of many ways, and in many embodiments the images of thepatient can be used to define a target volume and a target profile ofthe volume of tissue removed. The profile of tissue removed can beplanned to efficaciously remove tissue. The methods and apparatus forimaging as described herein can be used to beneficially plan fortreatment. Alternatively or in combination, the imaging methods andapparatus as described herein can be used to modify the treatment inreal time as the patient is treated, for example.

The visible entrainment region can be combined with the images of tissueand treatment regions shown on the display, so as to provideconfirmation that the correct amount of tissue will be resected. In manyembodiments, the distance of the visible entrainment region correspondsto a maximum cut depth, such that the surgeon can select the depth ofthe cut based on images and with adjustment of treatment parameters suchas one or more of flow rate, nozzle diameter, or pressure.

The visible entrainment region as described herein comprises region ofcavitation of the fluid stream emitted from the energy source such as anozzle, and the maximum resection depth corresponds to the distance ofthe visible entrainment region. By visible entrainment region, it ismeant that the user can visualize the entrainment region with imagingsensitive to formation of cavitation pockets, such as visible andultrasound imaging which scatter waves in response to cavitation pocketsbeing formed.

A plurality of carrier probes can be provided to allow the user to treatone or more of many tissues in a variety of ways. An elongate structuralelement having a working channel such as a shaft remains positioned inthe patient when a first carrier probe is exchanged with one or morecarrier probes. In many embodiments, the carrier probes can be rapidlyexchanged while a linkage remains fixedly attached to the elongateelement anchored to an internal structure of the patient. Each of thecarrier probes inserted into the patient can be identified based on atreatment plan, for example.

As used herein a processor encompasses one or more processors, forexample a single processor, or a plurality of processors of adistributed processing system for example. A controller or processor asdescribed herein generally comprises a tangible medium to storeinstructions to implement a steps of a process, and the processor maycomprise one or more of a central processing unit, programmable arraylogic, gate array logic, or a field programmable gate array, forexample.

As used herein, the transverse plane of an image may be referred to asthe horizontal plane of the image, the axial plane of the image, ortransaxial plane of the image. An image along an axial plane may bereferred to as an axial image.

As used herein, a probe encompasses an object inserted into a subjectsuch as a patient.

As used herein like characters identify like elements.

As used herein, a real time image shown on a display encompasses animage shown within a few seconds of the event shown. For example, realtime imaging of a tissue structure encompasses providing the real timeimage on a display within about ten seconds of the image being acquired.

As used herein, the terms distal and proximal refer to locationsreferenced from the apparatus, and can be opposite of anatomicalreferences. For example a distal location of a probe may correspond to aproximal location of an elongate member of the patient, and a proximallocation of the probe may correspond to a distal location of theelongate member of the patient.

Automated robotic control—where movement of the water jet is motorizedand under computer control with preselected routines—allows accurate andfinely detailed resections not possible with manual control. Advantagesinclude reduced time required for procedures, fewer complications,improved outcomes and less training time needed for surgeons. Many ofthese improvements arise from reducing or eliminating the need formanual dexterity of the treating physician. Automatic control furtherallows the cutting power of the nozzle to be increased to levels notachievable with full manual control. The system may be manuallycontrolled during less critical portions of the procedure, e.g. duringinitial selection of an area to operate on and for touch-ups in cuttingand cautery. Even during these less critical phases of the protocols,the increased precision and smoothness provided by the automated controlcan provide reduction and filtering of hand jitter. Another significantadvantage is that automation allows for pretesting or “dry runs” of aprocedure. When a cutting routine is selected, the limits of area can beselected using a joystick or other control element to position the laserduring a mock the procedure without cutting. Changes can be made beforecutting commences, so that errors can be corrected before beginning theactual procedure.

Closed-loop and real-time automation are new capabilities provided byrobotic automation include resection volume registration within theorgan and in-situ depth and volume measurement. With the ability toinput organ geometry data into the control system, e.g., from anultrasound or other pre-operative or real time image, the cutting regioncan be precisely registered within the organ. This eliminates theimprecision of manual procedures with respect to important tolerances,such as to how close the resection is to the surface of the capsuleand/or to the neurovascular bundle in the prostate. Additionally, theshape of the resected volume itself may be selectable and adjustablefrom a set of preprogrammed routines, where the details of how tocontrol the cutting motion and pressure have been worked out in advancewith extensive engineering knowledge that is then stored in the roboticsurgical tool, ready for access at the push of a button by the surgeon.For example, the resected shape of tissue may comprise a pre-definedtreatment profile such as one or more of domed, cubic, tear-drop, ordirectly from a 3D rendering of the target volume as described hereinand illustrated below in the two screenshots of FIGS. 21A and 21B, forexample. In addition, the surgeon can adjust the cutting parameters inreal-time based on the feedback provided by the ultrasound images, whichadds another layer of safety to the system.

INCORPORATION BY REFERENCE

The subject matter of FIGS. 1 to 11 and the corresponding text have beenincorporated by reference as described in: U.S. application Ser. No.12/700,568, filed Feb. 4, 2010, entitled “MULTI FLUID TISSUE RESECTIONMETHODS AND DEVICES”, published as US 20110184391 [Attorney Docket No41502-703.501]; and PCT Application PCT/US2011/023781 filed on Apr. 8,2007, published as WO2011097505 on Nov. 8, 2011, entitled “MULTI FLUIDTISSUE RESECTION METHODS AND DEVICES”; the full disclosures of whichhave been previously incorporated herein by reference.

Referring to FIG. 1, an exemplary prostatic tissue debulking device 10constructed in accordance with the principles of the present inventioncomprises a catheter assembly generally including a shaft 12 having adistal end 14 and a proximal end 16. The shaft 12 will typically be apolymeric extrusion including one, two, three, four, or more axiallumens extending from a hub 18 at the proximal end 16 to locations nearthe distal end 14. The shaft 12 will generally have a length in therange from 15 cm to 25 cm and a diameter in the range from 1 mm to 10mm, usually from 2 mm to 6 mm. The shaft will have sufficient columnstrength so that it may be introduced upwardly through the male urethra,as described in more detail below.

The shaft will include an energy source positioned in the energydelivery region 20, where the energy source can be any one of a numberof specific components as discussed in more detail below. Distal to theenergy delivery region, an inflatable anchoring balloon 24 will bepositioned at or very close to the distal end 14 of the shaft. Theballoon will be connected through one of the axial lumens to a ballooninflation source 26 connected through the hub 18. In addition to theenergy source 22 and the balloon inflation source 26, the hub willoptionally further include connections for an infusion/flushing source28, an aspiration (a vacuum) source 30, and/or an insufflation(pressurized C02 or other gas) source 32. In the exemplary embodiment,the infusion or flushing source 28 can be connected through an axiallumen (not shown) to one or more delivery ports 34 proximal to theballoon anchor 24 and distal to the energy delivery region 20. Theaspiration source 30 can be connected to a second port or opening 36,usually positioned proximally of the energy delivery region 20, whilethe insufflation source 32 can be connected to an additional port 38,also usually located proximal of the energy delivery region. It will beappreciated that the locations of the ports 34, 36, and 38 are notcritical, although certain positions may result in particular advantagesdescribed herein, and that the lumens and delivery means could beprovided by additional catheters, tubes, and the like, for exampleincluding coaxial sleeves, sheathes, and the like which could bepositioned over the shaft 12.

While the present embodiments are described with reference to the humanprostate, it is understood that they may be used to treat mammalprostates in general. Referring now to FIGS. 2A-2D, the prostatic tissuedebulking device 10 is introduced through the male urethra U to a regionwithin the prostate P which is located immediately distal to the bladderB. The anatomy is shown in FIG. 2A. Once the catheter 10 has beenpositioned so that the anchoring balloon 24 is located just distal ofthe bladder neck BN (FIG. 2B) the balloon can be inflated, preferably tooccupy substantially the entire interior of the bladder, as shown inFIG. 2C. Once the anchoring balloon 24 is inflated, the position of theprostatic tissue debulking device 10 will be fixed and stabilized withinthe urethra U so that the energy delivery region 20 is positioned withinthe prostate P. It will be appreciated that proper positioning of theenergy delivery region 20 depends only on the inflation of the anchoringballoon 24 within the bladder. As the prostate is located immediatelyproximal to the bladder neck BN, by spacing the distal end of the energydelivery region very close to the proximal end of the balloon, typicallywithin the range from 0 mm to 5 mm, preferably from 1 mm to 3 mm, thedelivery region can be properly located. After the anchoring balloon 24has been inflated, energy can be delivered into the prostate fordebulking, as shown by the arrows in FIG. 2. Once the energy has beendelivered for a time and over a desired surface region, the energyregion can be stopped and the prostate will be debulked to relievepressure on the urethra, as shown in FIG. 2D. At that time, a flushingfluid may be delivered through port 34 and aspirated into port 36, asshown in FIG. 2D. Optionally, after the treatment, the area could becauterized using a cauterizing balloon and/or stent which could beplaced using a modified or separate catheter device.

Referring now to FIGS. 3-7, a number of representative energy deliveryregions will be described. Referring now to FIG. 3, a first exemplaryprostate resection device 100 constructed in accordance with theprinciples of the present invention comprises a shaft 112 having aproximal end 114 and a distal end 116. A plurality of nozzles 118 aremounted on the shaft 112 at a location spaced proximally from the distalend 116 by distance in the range from 1 cm to 5 cm. The nozzles, whichare typically ceramic cores capable of generating a plasma or portscapable of directing a radially outward stream of electricallyconductive fluid, may be mounted on structure 120, which allows thenozzles 118 to be moved radially outwardly, as shown in broken line inFIG. 3. An anchor 122, shown as an inflatable balloon is mounted on thedistal end 116 of the shaft 112 at a location between the nozzles 118and the distal tip 124. The expandable structure 122 will be capable ofbeing expanded within the bladder to anchor the shaft 112 so that thenozzle array 118 lies within the prostate, as described in more detailbelow. The shaft 112 will include lumens, passages, electricallyconductive wires, and the like, in order to deliver energy and materialsfrom the proximal end 114 to the distal end 116 of the shaft. Forexample, an RF energy source 126 will be connected to the shaft 112,usually to the nozzles 118, in order to deliver RF energy to anelectrically conductive fluid delivered from source 128 to the nozzles118, typically through a lumen within the shaft 112. Other lumens,channels, or conduits will be provided in order to allow aspiration to avacuum source 130 which is typically connected to one or more aspirationports 132. Other conduits may be provided within the shaft 112 in orderto permit introduction of a flushing fluid, such as saline, from asource 134 to ports 136. In other instances, it will be possible toconnect the aspiration and flushing sources 130 and 134 to a common portso that aspiration and flushing may be conducted sequentially ratherthan simultaneously. Further optionally, internal lumens, conduits, orthe like, may be provided in order to connect a source of insufflation140 to one or more insufflation ports 142 on the shaft in the region ofthe array 118. Finally, internal lumens, conduits, or the like, may beprovided for connecting balloon 122 to a balloon inflation source 144.

As shown in FIG. 4, an exemplary energy delivery region 20 can be formedby a high pressure nozzle 200 which is carried on a delivery tube 202which is disposed within the shaft 12. Carrier tube 202 may be axiallytranslated as shown by arrow 204 and/or rotated as shown by arrow 206 sothat the fluid stream 208 emanating from the nozzle 200 can be scannedor rastered over all or a selected portion of the urethra within theprostate. Specific pressures and other details for such high pressurewater treatment are described, for example, in Jian and Jiajun, supra.

Referring now to FIG. 5, the energy source within the energy deliveryregion 20 may comprise a fiber-optic waveguide or fiber bundle 220carried on the rotating and translating shaft 202. The optical waveguide220 transmits laser or other coherent optical energy in a beam 222 whichmay be scanned or rastered over the urethral wall and prostatic tissueby rotating and/or translating the carrier tube 202.

As shown in FIG. 6, laser energy from an optical waveguide or fiberbundle 230 may be directed axially against a mirror 232, where thewaveguide and mirror are both carried on the rotating and axiallytranslating carrier tube 202. Again, by rotating and/or translating thecarrier tube 202, the emanating beam 234 can be scanned or rastered overthe urethral wall.

Referring now to FIG. 7, in yet another embodiment, the rotating andaxially translating tube 202 may carry an electrode 240 which projectslaterally from the tube. The electrode 240 will be adapted forconnection to a radiofrequency energy source so that, when the electrodecontacts the urethral wall and prostatic tissue, radiofrequency energycan be delivered, either in a monopolar or bipolar mode. Theradiofrequency energy can thus ablate the tissue over selected volumesand regions of the prostatic tissue. Optionally, by changing the natureof the radio frequency energy, the electrode 240 could also be used tocauterize the tissue after it has been treated.

In one embodiment of the present invention, the device is configured toselectively resect tissue, causing the removal of some tissuecompositions while leaving other tissue compositions intact. Forexample, the prostate and nearby regions comprise a variety of tissuecompositions, including glandular prostate tissue, intra-prostatevessels, fibromuscular stroma, capsular tissue, sphincter muscles,seminal vesicles, etc. When treating BPH or other prostate conditions,it is desirable to remove glandular prostate tissue and leave othertissues, such as vessels and capsular tissue, substantially undamaged.

As referred to herein, the term resection is meant to include anyremoval of tissue, including removal of one or more conglomerates oftissue cells, removal of fractions of tissue cells, etc.

One advantage of treating BPH by selective tissue resection is thereduced need (or no need) for cauterization, since there is little or nodamage to intra-prostate blood vessels and as a result there is limitedbleeding. Another advantage is a decreased chance of incontinence orimpotence, since selective resection decreases the risk of perforatingor otherwise damaging surrounding tissues, such as the prostate capsule,sphincter muscles, seminal vesicles, etc.

When using a fluid stream to resect tissue, selective tissue resectionmay be accomplished by varying one or more parameters of the fluidstream, such as the pressure within a nozzle or other fluid deliveryelement, or the flow rate of the fluid in the stream, so that it resectssome tissue compositions while leaving other tissue compositionssubstantially undamaged.

In one embodiment, the fluid stream parameters may be configured toleave non-target tissues substantially undamaged even when those tissuesare exposed to the fluid stream for an extended period of time, i.e.,typically a period of time that is sufficient to achieve the desiredresection. In another embodiment, the fluid stream parameters may beconfigured to resect the target tissue at a substantially higher ratethan the non-target tissue, thereby limiting damage to non-targettissue. Such parameters may be adjusted, depending on the target tissuethat is to be selectively resected.

In one embodiment, the rate of resection is configured to be higher forglandular tissue than for non-glandular tissue. The rate of resectionmay be configured by altering the pressure of the fluid, or by adjustingother fluid parameters, as described above. In particular, the rate ofresection for glandular tissue may be configured to be significantlyhigher than that for non-glandular tissue, such that during thetreatment period non-glandular tissue remains effectively undamaged. Forexample, the rate of resection of glandular tissue may be configured tobe at least twice as high as that for non-glandular tissue. As anotherexample, the rate of resection for glandular tissue may be configured tobe at least 10 times as high as that for non-glandular tissue.

It is noted that tissue resection has a critical pressure (which is apressure below which tissue does not resect and above which tissue canbe resected) because the removal process involves tearing of the tissue,wherein tissue is stretched on a micro scale to the point where thetissue matrix ruptures or tears. Since tissue is elastic, there will bea critical breaking point. Different types of tissue will have differentcritical breaking points, and hence different critical pressuresassociated with them.

Indeed, given a particular fluid delivery element size (such as nozzlediameter), each tissue type typically has a critical pressure of thefluid stream source (hereinafter also referred to as Pcrit) below whichthe rate of resection approaches zero, and above which the rate ofresection generally increases monotonically, and possibly exponentially.Specifically, due to differences in tissue composition, the pressure ofthe fluid stream source may be configured to selectively resect aparticular type of tissue while leaving other tissue types with highercritical pressures generally undamaged.

An important aspect of resecting tissue in a multi-tissue environmentaccording to the present embodiments is that it is possible to operatein a regime where one tissue type is resected and another tissue typeremains substantially undamaged. This happens most strongly whenoperating at a pressure between the critical pressures of the two tissuetypes. As seen in FIG. 8, the operating pressure p0 of the fluid streammay be configured to be greater than the critical pressure of tissue 1(p0>pcrit1) so that tissue 1 experiences a resection rate that isgreater than zero, while keeping the pressure p0 less than the criticalpressure of tissue 2 (p0<pcrit 2) so that tissue 2 experiences a rate ofresection that is substantially near zero. In such a configuration, thefluid stream is said to be configured to selectively resect tissue 1 butnot tissue 2.

In one embodiment configured to treat BPH, the fluid stream sourcepressure is configured to be above the critical pressure of glandularprostate tissue but below the critical pressure of non-glandularprostate tissue. In such an embodiment, the pressure is sufficientlyhigh to resect glandular tissue, but too low to substantially resect ordamage non-glandular tissue such as intra-prostate blood vessels,fibromuscular stroma, capsular tissue, etc. In one embodiment, the fluidis pressurized to a pressure within the range of about 1-30,000 psibefore leaving the fluid delivery element, more preferably to a pressurewithin the range of about 50-1,500 psi, and most preferably to apressure within the range of about 100-1,000 psi.

The following example illustrates some tissue critical pressures forfluid stream resection. It is noted that the following configurationsare provided as an example and should not be construed as limiting.

Example 1

Exemplary critical pressures of different kidney tissue compositions.Tissue critical pressures were measured in pig kidneys. Kidney tissuewas chosen because its composition is similar to that of the prostatetissue. A columnar fluid stream of approximately 200 microns in diameterwas used for tissue resection. The glandular tissue (the pink outerportion of the kidney) is very soft, and easily tears with fingerpressure, while the inside of the kidney comprises tougher vasculartissue. The critical pressure for the glandular tissue with this fluidstream was found to be about 80 psi, and about 500 psi for the vasculartissue, as seen in Table 1 below.

Table 1 of Different critical pressures of glandular and vasculartissues in pig kidney. Tissue P_(crit) (psi) Glandular 80 Vascular 500

For example, experiments show that when resecting pig kidney using anozzle of approximately 200 microns in diameter with liquid sourcepressure of about 500 psi, the rate of resection over a 10 cm area isabout 1 cm per 30 sec for glandular tissue (i.e., removal of 10 cc per30 sec), and less than about 0.1 cm per 180 sec for vascular tissue,which is about a sixty-fold difference in resection rates. Thus, withinthe same resection time period, more glandular tissue will be resectedthan vascular tissue. Thereby, the resection time period can beconfigured to allow resection of glandular tissue without substantialdamage to vascular tissue. The rate of resection may be adjusted byvarying the fluid source pressure and/or the size of the nozzle. Forexample, the rate of resection for glandular tissue may be adjusted toabout 1 cc per min, 5 cc per min, 10 cc per min, 30 cc per min, or otherrates. As noted above, it is understood herein that varying the size ofthe nozzle may necessitate varying the fluid source pressure in order tocause the fluid stream to impinge with sufficient force upon tissue toachieve desired resection rates.

FIG. 9a is a flow diagram illustrating a method for selective prostateresection, according to one embodiment. At step 700, the device ispositioned and anchored in the urethra, as described above. At step 701,various fluid parameters such as the pressure of the fluid source, shapeof the fluid stream, etc., are configured to resect a specific tissuetype, such as glandular prostate tissue. By configuring the fluidparameters one can control fluid force, rate of resection, treatmenttime, area of tissue to be resected, etc., in order to achievecontrolled and selective resection. After the parameters are configured,at step 702, the device is configured to discharge a fluid stream toresect the target tissue. At step 703, if it is determined that thetreatment is complete, the device is withdrawn from the urethra U atstep 704.

However, if at step 703 it is determined that the treatment is not yetcomplete, then the fluid parameters may be re-configured as needed, asdescribed in step 701, and the cycle of steps repeats until treatment iscomplete. In particular, re-configuration of the fluid parameters isadvantageous in an embodiment where it is desired to resect twodifferent types of tissues for a complete treatment. In such anembodiment, the fluid parameters may be adjusted to take into accountthe change in the type of target tissue that is to be resected.

Typically, after some or all of the glandular tissue has been resected,other tissue types such as vascular or capsular tissue will be exposedto the fluid stream. While the fluid stream parameters are configured toselectively resect glandular tissue, it is also contemplated that thefluid parameters may be dynamically adjusted during the resectionprocedure to take into account the gradual exposure of non-glandulartissue and to fine-tune the resection selectivity as needed. After thefluid parameters are thusly re-configured at step 701, then at step 702the re-configured fluid stream is emitted to continue tissue resection,and the operation continues until the treatment is complete.

Specifically, it is noted that when treating the prostate from withinthe urethra, the urethral wall is interposed between the source of thefluid stream (such as a nozzle or other fluid delivery element) and thetarget glandular prostate tissue that is to be resected.

Therefore, in one embodiment, the fluid stream parameters are initiallyconfigured to resect and penetrate a portion of urethral tissue (e.g.,the urethral wall). However, since the composition of glandular prostatetissue is weaker than that of the urethral tissue, it is desirable toavoid resecting glandular tissue with the same fluid stream force asthat used to resect the urethral wall. To accomplish this, the fluidstream may be used for a period of time that is sufficient to resect andpenetrate the urethral wall, and not longer. Thereafter, a fluid streamof reduced strength may be used to resect glandular prostate tissue.

FIG. 9b is a flow diagram illustrating a method for selective prostateresection, wherein the fluid stream is configured to first penetrate andresect the urethral wall, according to one embodiment. At step 801, thedevice is positioned and anchored in the urethra, as described above. Atstep 802, the device is configured to discharge a fluid stream ofsufficient force to resect and penetrate the urethral wall. At step 803,after the fluid stream has penetrated the urethral wall, the fluidstream is adjusted to a level that selectively resects the desiredprostate tissue while leaving intra-pro state blood vessels, capsules,and other non-glandular tissue substantially undamaged.

In addition, it is contemplated that the shape of the fluid stream alsoaffects selective resection. While the fluid stream is exemplarily shownin FIG. 10a as a columnar fluid stream 333 or diverging fluid stream334, it is contemplated that the fluid stream may be of any shape orconfiguration that allows resection according to the presentembodiments. In particular, there are numerous advantages to both thecolumnar fluid stream configuration and the diverging fluid streamconfiguration, as will be described further below.

In a columnar fluid stream configuration 333, the device emits the fluidstream as a substantially focused rod-like fluid column that has asubstantially zero divergence angle. In one embodiment, the columnarfluid stream is configured as a generally straight or non-divergingfluid stream. In such configuration, the device emits the fluid streamsubstantially as a cylinder or other non-diverging shape, therebytransmitting energy to the tissue over an area or spot size that islargely independent of the tissue distance from the fluid deliveryelement. Optionally, the fluid stream may be adjusted to converge, forexample if the fluid delivery element comprises multiple nozzles or ifthe fluid contains bubbles, in order to focus the energy delivered totissue.

FIG. 10b shows a cross-sectional view of the device emitting a columnarfluid stream to modify a tissue such as the prostate. An elongateelement 310 (such as a shaft, as described above) of the device isdisposed within the urethra U. A fluid delivery element 320 disposed onthe carrier tube (not shown) within the elongate element 310 isconfigured to emit a columnar fluid stream 333. As understood herein,the fluid delivery element 320 may comprise a nozzle, as describedabove, or any other element configured to emit fluid. The columnar fluidstream 333 is configured to resect tissue, such as the urethral wall UWand the prostate tissue P, within a resection area RA.

One characteristic of the columnar fluid stream configuration is thatthe resection area RA remains substantially constant for some distancefrom the fluid delivery element 320, since the width of the resectionarea RA is substantially independent of the fluid distance from thefluid delivery element 320. This is advantageous because the resectionarea RA remains focused and constant as the fluid stream 333 travelsaway from the fluid delivery element 320, thereby transmitting energy tothe tissue at a focal area. The concentration of energy within a focusedresection area RA is particularly advantageous when resecting orpenetrating tough tissue, such as the urethral wall UW. In oneembodiment, the columnarity of the fluid stream may be varied byintroducing pressure fluctuations in the fluid delivery. For example,the columnarity of the fluid stream may be varied by mechanically andcontrollably introducing a generally solid object in the fluid deliverypath, such as behind an aperture of the fluid delivery element 320 or inthe path of the fluid stream after it exits an aperture of the fluiddelivery element 320. In another example, the columnarity of the fluidstream may be varied by introducing a vibrating element in the fluidpathway, such as a piezoelectric element or the like, to create pressurefluctuations.

In another embodiment, the fluid stream is configured as a divergingfluid stream 334, as seen in FIG. 10a . A diverging fluid stream 334 isone in which the fluid exits a fluid stream source, such as the fluiddelivery element 320, and diverges substantially in a cone, wherein thetip of the cone is at the fluid stream source. The rate of resection ofa diverging fluid stream 334 can be represented as a function of thedistance z from the fluid emitting fluid delivery element 320 to thetissue that is to be resected. As shown in FIG. 10a , z2 is further awayfrom the orifice than z1, and accordingly the rate of resection at z1 ishigher than the rate of resection at z2.

The diverging fluid stream 334 may be characterized by the angle ofdivergence of the fluid stream. In one embodiment, the angle ofdivergence is configured to be about 0-90 degrees, more preferably about2-45 degrees, more preferably about 4-20 degrees, and most preferablyabout 7 degrees, while it is also contemplated that the angle ofdivergence may be varied as needed.

Additionally, the diverging fluid stream 334 may be characterized by thecross-sectional shape of the fluid stream. Generally, the divergingfluid stream 334 has a cross-sectional area, or spot-size, thatincreases at distances further from the fluid stream source (e.g., fluiddelivery element 320), thereby proportionally reducing the force of thefluid stream per unit area. This increase of spot-size generally resultsin greater resection rates of tissue closer to the fluid stream source.

In one embodiment, the cross-sectional shape of the diverging fluidstream 334 is configured as a generally narrow rectangle (for afan-shaped fluid stream). In another embodiment, the cross-sectionalshape of the diverging fluid stream 334 is configured as generally acircle (for a conical-shaped fluid stream), wherein the smallestcross-sectional area is at the fluid stream source. It is noted that thecross-sectional shape of the diverging fluid stream 334 may beconfigured as any shape that encloses a non-zero area (e.g., an ellipse,or an irregular shape).

FIG. 10c shows a cross-sectional view of the device emitting a divergingfluid stream to modify tissue such as the prostate. An elongate element310 of the device is disposed within the urethra U. A fluid deliveryelement 320 disposed on the carrier tube (not shown) within the elongateelement 310 is configured to emit a diverging fluid stream 334. Thediverging fluid stream 334 is configured to resect tissue such as theurethral wall UW and the prostate tissue P within a resection area RA.The resection area RA covered by the diverging fluid stream 334increases as the fluid stream travels away from the fluid deliveryelement 320, thereby proportionally reducing the strength of the fluidstream per unit area.

A characteristic of the diverging fluid stream 334 is that the resectionwidth increases as a function of distance from the fluid deliveryelement 320, while the rate of resection per unit area decreases as afunction of distance from the fluid delivery element 320. This isbecause the total energy delivered in the fluid stream is generallyconstant (not taking into account any decrease in fluid speed), yet theenergy is delivered over a larger area. Thus, the energy delivered perarea decreases, which is a key parameter upon which the rate ofresection depends. Therefore, the rate of resection per unit areadecreases as a function of distance.

Furthermore, in a diverging fluid stream 334 the volumetric rate ofresection may be substantially constant as a function of distance. Thatis, while the rate of resection per unit area decreases, the total arearesected increases proportionately, and hence the total resected volumeremains substantially constant. It is noted that if the areal rate ofresection as a function of areal energy density is non-linear andmonotonically increasing with energy, then the volumetric rate ofresection will decrease as function of distance from the fluid deliveryelement 320. It is further noted that any slowing of the fluid streamparticles (for example, liquid droplets) will also decrease thevolumetric resection rate as a function of distance.

Referring now to FIG. 11, the device comprises an elongate element 310,such as a shaft, configured to be inserted into a body region. Theelongate element 310 comprises a window exposing a carrier tube 380 andother components described below. The window reveals a carrier tube 380and a high pressure fluid delivery element 320 disposed on the carriertube 380. The fluid delivery element 320 is connected to a fluid source(not shown) via a fluid lumen 390 which delivers fluid from the sourceto the fluid delivery element 320.

Optionally, when the elongate element 310 is introduced through theurethra, the elongate element 310 may be covered by a sheath or othercover (not shown). When fully covered with the sheath, the window isprotected so that it reduces scraping and injury to the urethra as theelongate element 310 is advanced. Once in place, the sheath isretracted, exposing the window. The carrier tube 380 may then be rotatedand advanced and/or retracted so that the fluid is delivered through thefluid delivery element 320.

Additionally and optionally, the device may comprise a shield element(not shown) that is positioned to substantially cover the fluid deliveryelement 320 while maintaining a space between the fluid delivery element320 and the shield element. This in return effectively maintains thatspace between the fluid delivery element 320 and any tissue that mightimpinge on the shield element. In one embodiment, the shield element isa substantially flat sheet-like element positioned over the fluiddelivery element 320. The shield element is positioned or shaped suchthat it allows the carrier tube 380 to move within the elongate element310 as needed. For example, the shield element may be curved to follow acurvature of the carrier tube 380. The shield element comprises anopening to allow the fluid stream emitted by the fluid delivery element320 to travel unobstructed through the opening and impinge on thetissue. The opening may be circular, or it may comprise other shapes.One advantage of such a shield element is that it protects the fluiddelivery element 320 from being damaged during insertion or removalprocedures and/or during treatment. Another advantage of the shieldelement is that, during or after fluid emission, fluids that arereturning back towards the fluid delivery element 320 may travel throughthe shield element opening (or through other paths around the shieldelement) and into the space between the shield element and the fluiddelivery element 320. Such returned fluids may then be channeled out ofthat space such that fluid emission is not obstructed or hindered bysuch returned fluids.

The shield element may further be configured such that the space betweenthe shield element and the fluid delivery element 320 is in continuouscommunication with a waste disposal lumen via a low-flow-resistancefluid path. This creates a low-flow-resistance path between the fluiddelivery element 320 and an external destination of such waste, suchthat waste and fluids leaving the fluid delivery element 320 may easilyleave the region surrounding the fluid delivery element 320. Lowresistance in this case is understood to mean a flow resistance that islower in comparison with a flow resistance of the fluid delivery element320. This configuration advantageously prevents back-pressure at thefluid delivery element 320, which would otherwise reduce flow, andthereby allows the fluid stream emitted by the fluid delivery element320 to travel substantially undisturbed by waste and return fluids.

The fluid delivery element 320 may be a single nozzle, a plurality ofnozzles, or an array of nozzles of various configurations. The fluiddelivery element 320 is configured to emit a fluid radially outwardly asa fluid stream 331, with sufficient force so that upon contact with thetissue the fluid stream 331 resects the tissue. The fluid stream 331 maybe perpendicular to the elongate element 310, or it may be configured tobe at various angles relative to the elongate element 310.

The carrier tube 380 may be axially translated, rotated, oscillated, orrotationally oscillated relative to the elongate element 310 so that thefluid stream 331 can be scanned or rastered to resect a desired area orvolume of the tissue. The desired area or volume may be spherical,cylindrical, or any other predetermined area or volume of arbitraryshape and dimension.

Additionally and optionally, when the device is not being used to resecttissue, the carrier tube 380 may be positioned so that the fluiddelivery element 320 and/or any other elements (such as visualization orcauterization elements) are positioned away from the window, therebyreducing the risk of damage to such elements, as well as reducing anyrisk of unintentional resection of the tissue.

The device further comprises at least one insufflation port 340 disposedon the elongate element 310. The insufflation port 340 is connected viaone or more lumens to an insufflation source (not shown), wherein theinsufflation source delivers a fluid 330 into the body region throughthe insufflation port 340 in order to expand the surrounding tissue andcreate a working space. The device further comprises at least oneremoval port 360 for the removal of debris products, such as resectionproducts, resection fluid, other waste products, or a mixture thereof.The elongate element 310 may include lumens, passages, electricallyconductive wires, and the like, configured to deliver energy and/ormaterials from the proximal end to the distal end of the elongateelement 310 and/or to remove debris and waste products, details of whichare described above.

Optionally, in addition to the fluid delivery element 320, the devicemay comprise an electromagnetic energy delivery port 350 disposed on thecarrier tube 380 and positioned near or within the fluid deliveryelement 320. Electromagnetic energy 332 is delivered to the energydelivery port 350 by means of one or more conduits 351, such as opticalfibers or other waveguides within the carrier tube 380 and the elongateelement 310, as also described in greater detail above. Theelectromagnetic energy 332 may be radiofrequency energy, coherent ornon-coherent light, or any other modality of electromagnetic energy. Theenergy delivery port 350 is configured to deliver the energy 332 throughthe interior of the fluid stream 331 so that the electromagnetic energy332 may resect the tissue in lieu of, or in combination with, the fluidresection.

Additionally and optionally, the various electromagnetic energymodalities described above may be configured to cauterize the tissue, incombination with tissue resection, or independently thereof. Sinceselective tissue resection as disclosed herein generally causes littleor no damage to remaining tissue such as vascular tissue and thereforecauses limited or no bleeding, such cauterization need only be used on alimited basis, if at all. It is contemplated that when electromagneticenergy is delivered to the tissue by the fluid stream 331 forcauterization, the fluid source pressure may be adjusted to be generallybelow the critical pressure for tissue resection such that no additionaltissue is resected.

Alternatively or additionally, cauterization may be achieved using othermeans, for example using a cauterizing balloon and/or stent placed incontact with tissue using a catheter device, as described above.

Furthermore, the device may comprise optional deflective elements, forexample positioned within the interior or the elongate element 310 andaway from the window, configured to deflect fluid, emitted by the fluiddelivery element 320, back towards the fluid delivery element 320,thereby removing any debris that may have accumulated on the fluiddelivery element 320 and/or energy delivery port 350 during tissueresection. Furthermore, the fluid delivery element 320 in combinationwith the deflective elements may be configured to clean a part of, orsubstantially the entirety of, the fluid delivery element 320, anyvisualization or cauterization elements, and/or carrier tube 380. Thedeflective element may be configured to be substantially flat orconcave. Alternatively the deflective element may be configured as anyshape or design.

Additionally, the deflective element may act be configured as aprotective element for the fluid delivery element. The fluid deliveryelement may be positioned at a specific location relative to theprotective element that protects the prostate from unexpected fluidemissions and protects the fluid delivery element 320 from, for example,clogging or obstruction by tissue, especially during insertion andremoval from the body.

The carrier tube 380 comprises a carrier. The carrier may optionallycomprise a tubular structure. Although reference is made to a carriertube 380 in accordance with embodiments, the carrier may comprise asubstantially non-tubular cross-section, for example a rectangular crosssection, extending along a substantial portion of the carrier asdescribed herein. Therefore, it is to be understood that although thecarrier tube shown and described in the drawings, the carrier maycomprise a non-circular carrier in each of the drawings and supportingtext as described herein.

FIG. 12 shows a component of treatment probe 350 in accordance withembodiments. A carrier tube 380 comprises a concentric configuration ofa first fluid delivery port and a second fluid delivery port. Fluiddelivery element 320 releases fluid stream 331. Fluid stream 331 definesan axis extending from the fluid delivery element 320 outward. The fluidstream 331 may comprise a diverging stream 334 or a columnar stream 333as described herein. Fluid delivery element 320 comprises a nozzle 322.Nozzle 322 may comprise a substantially circular cross section. Thenozzle 322 may comprise an internal channel having the circular crosssection in which the internal channel extends cylindrically. Theinternal channel extends along an axis corresponding to the axis of thefluid stream 331.

Concentrically disposed around the fluid delivery element 320 is a port340. The port 340 comprises a substantially annular channel extendingcircumferentially around fluid delivery element 320 and nozzle 322. Port340 may comprise an insufflation port as described herein. Port 340releases fluid 330 in a substantially concentric arrangement with fluidstream 331. The substantially concentric arrangement has the advantageof providing a protective jacket around fluid stream 331 with firstfluid 330 extending outward from port 340 so as to beneficially directthe treatment stream toward the tissue. Energy conduit 351 extends froma source of energy such as a laser toward fluid delivery element 320.The energy conduit may comprise an optical fiber or a plurality ofoptical fibers coupled to a laser, for example. The optical fiber canextend toward nozzle 322 and can be concentrically aligned with the axisdefined by nozzle 322 so as to provide efficient energy transmission ofthe light energy emitted from the optical fiber through the nozzle 322.A structure can be provided near the distal end of the optical fiber inorder to align the optical fiber with the channel of nozzle 322. Theconcentric alignment of the optical fiber, the nozzle and the port 340can provide therapeutic treatment of the patient that allowsvisualization and treatment of the patient. The fluid release from port340 may comprise a liquid, for example saline, or a gas, for exampleCO2. The fluid delivered through port 340 can be user selectable withthe interface as described herein.

The fluid stream 331 can provide an optical wave guide directed towardthe tissue. In many embodiments the fluid stream 331 comprises an indexof refraction greater than the fluid released through port 340. The waveguide media can be a liquid or gas and the jacketing media released fromport 340 can be a liquid or gas. An intermediate media can be locatedbetween the probe and the target tissue. The intermediate media can be aliquid or gas, for example, one or more of saline, air or carbondioxide. In many embodiments the intermediate media comprises a fluidrelease from nozzle 322 and a fluid release from annular port 340.

FIGS. 13A and 13B show a system that treat a patient in accordance withembodiments. The system 400 comprises a treatment probe 450 and mayoptionally comprise an imaging probe 460. The treatment probe 450 iscoupled to a console 420 and a linkage 430. The imaging probe 460 iscoupled to an imaging console 490. The patient treatment probe 450 andthe imaging probe 460 can be coupled to a common base 440. The patientis supported with the patient support 449. The treatment probe 450 iscoupled to the base 440 with an arm 442. The imaging probe 460 iscoupled to the base 440 with an arm 444.

The patient is placed on the patient support 449, such that thetreatment probe 450 and ultrasound probe 460 can be inserted into thepatient. The patient can be placed in one or more of many positions suchas prone, supine, upright, or inclined, for example. In manyembodiments, the patient is placed in a lithotomy position, and stirrupsmay be used, for example. In many embodiments, the treatment probe 450is inserted into the patient in a first direction on a first side of thepatient, and the imaging probe is inserted into to the patient in asecond direction on a second side of the patient. For example, thetreatment probe can be inserted from an anterior side of the patientinto a urethra of the patient, and the imaging probe can be insertedtrans-rectally from a posterior side of the patient into the intestineof the patient. The treatment probe and imaging probe can be placed inthe patient with one or more of urethral tissue, urethral wall tissue,prostate tissue, intestinal tissue, or intestinal wall tissue extendingtherebetween.

The treatment probe 450 and the imaging probe 460 can be inserted intothe patient in one or more of many ways. During insertion, each arm maycomprise a substantially unlocked configuration such the probe can bedesirably rotated and translated in order to insert the probe into tothe patient. When a probe has been inserted to a desired location, thearm can be locked. In the locked configuration, the probes can beoriented in relation to each other in one or more of many ways, such asparallel, skew, horizontal, oblique, or non-parallel, for example. Itcan be helpful to determine the orientation of the probes with anglesensors as described herein, in order to map the image date of theimaging probe to treatment probe coordinate references. Having thetissue image data mapped to treatment probe coordinate reference spacecan allow accurate targeting and treatment of tissue identified fortreatment by an operator such as the physician.

In many embodiments, the treatment probe 450 is coupled to the imagingprobe 460. In order to align the treatment with probe 450 based onimages from imaging probe 460. The coupling can be achieved with thecommon base 440 as shown. Alternatively or in combination, the treatmentprobe and/or the imaging probe may comprise magnets to hold the probesin alignment through tissue of the patient. In many embodiments, the arm442 is a movable and lockable arm such that the treatment probe 450 canbe positioned in a desired location in a patient. When the probe 450 hasbeen positioned in the desired location of the patient, the arm 442 canbe locked with an arm lock 427. The imaging probe can be coupled to base440 with arm 444, can be use to adjust the alignment of the probe whenthe treatment probe is locked in position. The arm 444 may comprise alockable and movable probe under control of the imaging system or of theconsole and of the user interface, for example. The movable arm 444 maybe micro-actuable so that the imaging probe 440 can be adjusted withsmall movements, for example a millimeter or so in relation to thetreatment probe 450.

In many embodiments the treatment probe 450 and the imaging probe 460are coupled to angle sensors so that the treatment can be controlledbased on the alignment of the imaging probe 460 and the treatment probe450. An angle sensor 495 is coupled to the imaging probe 450 with asupport 438. An angle sensor 497 is coupled to the imaging probe 460.The angle sensors may comprise one or more of many types of anglesensors. For example, the angle sensors may comprise goniometers,accelerometers and combinations thereof. In many embodiments, anglesensor 495 comprises a 3-dimensional accelerometer to determine anorientation of the treatment probe 450 in three dimensions. In manyembodiments, the angle sensor 497 comprises a 3-dimensionalaccelerometer to determine an orientation of the imaging probe 460 inthree dimensions. Alternatively or in combination, the angle sensor 495may comprise a goniometer to determine an angle of treatment probe 450along an elongate axis of the treatment probe. Angle sensor 497 maycomprise a goniometer to determine an angle of the imaging probe 460along an elongate axis 461 of the imaging probe 460. The angle sensor495 is coupled to a controller 424. The angle sensor 497 of the imagingprobe is coupled to a processor 492 of the imaging system 490.Alternatively, the angle sensor 497 can be coupled to the controller 424and also in combination.

The console 420 comprises a display 425 coupled to a processor system incomponents that are used to control treatment probe 450. The console 420comprises a processor 423 having a memory 421. Communication circuitry422 is coupled to processor 423 and controller 422. Communicationcircuitry 422 is coupled to the imaging system 490. The console 420comprises components of an endoscope coupled to anchor 24. Infusionflushing control 28 is coupled to probe 450 to control infusion andflushing. Aspiration control 30 is coupled to probe 450 to controlaspiration. Endoscope 426 can be components of console 420 and anendoscope insertable with probe 450 to treat the patient. Arm lock 427of console 420 is coupled to arm 422 to lock the arm 422 or to allow thearm 422 to be freely movable to insert probe 450 into the patient. Theconsole 420 comprises a light source 33.

The console 420 may comprise a pump 419 coupled to the carrier andnozzle as described herein.

The processor, controller and control electronics and circuitry caninclude one or more of many suitable components, such as one or moreprocessor, one or more field-programmable gate array (FPGA), and one ormore memory storage devices. In many embodiments, the controlelectronics controls the control panel of the graphic user interface(hereinafter “GUI”) to provide for pre-procedure planning according touser specified treatment parameters as well as to provide user controlover the surgery procedure.

The treatment probe 450 comprises an anchor 24. The anchor 24 anchorsthe distal end of the probe 450 while energy is delivered to energydelivery region 20 with the probe 450. The probe 450 may comprise anozzle 200 as described herein. The probe 450 is coupled to the arm 422with a linkage 430.

The linkage 430 comprises components to move energy delivery region 20to a desired target location of the patient, for example, based onimages of the patient. The linkage 430 comprises a first portion 432 anda second portion 434 and a third portion 436. The first portion 432comprises a substantially fixed anchoring portion. The substantiallyfixed anchoring portion 432 is fixed to support 438. Support 438 maycomprise a reference frame of linkage 430. Support 438 may comprise arigid chassis or frame or housing to rigidly and stiffly couple arm 442to treatment probe 450. The first portion 432 remains substantiallyfixed, while the second portion 434 and third portion 436 move to directenergy from the probe 450 to the patient. The first portion 432 is fixedto the substantially constant distance 438 to the anchor 434. Thesubstantially fixed distance 438 between the anchor 24 and the fixedfirst portion 432 of the linkage allows the treatment to be accuratelyplaced. The first portion 434 may comprise the linear actuator toaccurately position the high pressure nozzle in treatment region 20 at adesired axial position along an elongate axis of probe 450.

The elongate axis of probe 450 generally extends between a proximalportion of probe 450 near linkage 430 to a distal end having anchor 24attached thereto. The third portion 436 controls a rotation angle aroundthe elongate axis. During treatment of the patient, a distance 439between the treatment region 20 and the fixed portion of the linkagevaries with a reference distance 439. The distance 439 adjusts inresponse to computer control to set a target location along the elongateaxis of the treatment probe referenced to anchor 24. The first portionof the linkage remains fixed, while the second portion 434 adjust theposition of the treatment region along the axis. The third portion ofthe linkage 436 adjusts the angle around the axis in response tocontroller 424 such that the distance along the axis at an angle of thetreatment can be controlled very accurately with reference to anchor 24.The probe 450 may comprise a stiff member such as a spine extendingbetween support 438 and anchor 24 such that the distance from linkage430 to anchor 24 remains substantially constant during the treatment.The treatment probe 450 is coupled to treatment components as describedherein to allow treatment with one or more forms of energy such asmechanical energy from a jet, electrical energy from electrodes oroptical energy from a light source such as a laser source. The lightsource may comprise infrared, visible light or ultraviolet light. Theenergy delivery region 20 can be moved under control of linkage 430 suchas to deliver an intended form of energy to a target tissue of thepatient.

The imaging system 490, a memory 493, communication circuitry 494 andprocessor 492. The processor 492 in corresponding circuitry is coupledto the imaging probe 460. An arm controller 491 is coupled to arm 444 toprecisely position imaging probe 460.

FIG. 14A shows a multipurpose sheath and manifold in accordance withembodiments. A manifold 468 is configured to transmit a plurality offluids to and from the working site. Manifold 468 is rigidly coupled,for example affixed, to the spine 452. A sheath 458 is located aroundspine 452 and can extend inward toward the manifold 468. The manifold468 is coupled with a locking element 460 to support 438 in linkage 430.Manifold 468 can be decoupled from the linkage 430 and the support 438so as to remove the linkage 430 and support 438 to permit additionalcomponents to be inserted into the working channel. For example, anendoscope can be inserted into the working channel to extend toward theworking area of the organ, for example, the prostate. A structure 462comprising a nose portion extends toward manifold 468. Structure 462 isshaped to engage manifold 468 and allow removal of structure 462,linkage 430 and support 438 when locking element 460 is disengaged.Manifold 468 comprises a structure 464 to engage in nose portion ofstructure 462. A plurality of seals are arranged on manifold 468 toallow removal of structure 462. When structure 462 has been removed anendoscope or other surgical tool can be inserted into the working spaceand advance toward the treatment site. For example an endoscope can beadvanced toward the treatment site to be the treatment area. Themanifold comprises a plurality of ports that are coupled to thetreatment site to allow fluid to be transmitted and removed from thetreatment site. For example when an endoscope has been placed at thetreatment site. The locking element and manifold allow for removal ofthe linkage and treatment probes such that the manifold 468 remainscoupled to sheath 458 and spine 452 within the patient.

In many embodiments treatment probes and carriers as described herein,for example tubular carriers, can be inserted and removed while thelocking element 460 engages the linkage 430 and support 438. Thisconfiguration of the linkage, locking element and support allow probesto be rapidly and easily removed and reinserted to provide beneficialtreatments.

The multipurpose sheath and manifold as described herein has the benefitof allowing the sheath, manifold, spine and anchor to remain attached tothe patient while additional surgical tools are employed. The lockingelement interfaces with multiple instruments allowing for placement,visualization, and aquablation and aquabeam operations, withoutreintroduction or movement with respect to the tissue. Multiple sealedconduits allow for sheath ports to be used to transmit flow or pressureof varying fluids within or parallel to the working channel. The workingchannel may be used for visualization access to anatomy via existingrigid or flexible endoscope technology. The working channel has a largebore to accommodate many types of tools and allow for free flow oftissue and fluids. Alternate energy delivery devices may be used withinthe sheath or working channel as described herein.

In many embodiments the working channel is sized to allow a plurality ofcarriers within the working channel. For example, an endoscope carrierwithin the working channel and a treatment probe carrier as describedherein within the working channel so as to allow visualization of thetreatment site while the treatment probe performs aquablation and aquabeam operations as described herein.

FIG. 14B shows manifold conduits of the manifold configured fortransmitting and receiving multiple fluids while the manifold remainscoupled to the patient. The manifold is coupled to a plurality of ports456. The plurality of ports 456 may comprise an auxiliary fluid port456A, a balloon pressure port 456B and a tissue removal port 456C. Asheath 458 extends circumferentially around spine 452. The spine 452 andsheath 458 can be rigidly coupled to the manifold portion and provideconnections and channels coupled to the manifold portion. A channel 467,for example a tubular channel, is connected to port 456B to allow forinflation of the balloon. A channel 469 can be defined with sheath 458.Channel 469 can be coupled to port 456A to provide an auxiliary fluid tothe treatment site. Port 456C to allow removal of tissue can be coupledto the main working channel 465. The main working channel 465 can extendfrom port 456C to the treatment site. A plurality of seals 466 arearranged to separate the treatment ports and channels as describedherein. The manifold 468 can be decoupled from the linkage 430 andsupport 438 and allow balloon inflation pressure to be applied throughport 456B. An auxiliary fluid can be provided through port 456A, forexample, so as to flush the working channel 465. This configuration ofthe manifold allows the spine 452 and anchor 24 to remain in place whenother instruments have been inserted into the working channel.

The plurality of manifold conduits as described herein allow tissuecollection to be routed through the large bore working channel 469 toreduce flow obstructions. Balloon pressure can be transmitted from alure fitting to the distal tip of the anchor with small diameter tubing,for example, tubing defining channel 467. An auxiliary fluid istransmitted between the sheath and spine to the treatment area withchannel 469.

FIG. 14C shows components of treatment probe and linkage disassembledprior to use. The linkage 430 comprises a casing 410 and a cover 412.The cover 412 can be placed on the lower portion of the casing 410. Thecover and casing may comprise rigid materials to add stiffness. Thecasing and cover can be sized so as to comprise a handpiece containingthe linkage 430. The linkage 430 comprises an elongate tubular structurecomprising a gear 433 to engage another gear 434 of the linkage. Thegear 434 can be positioned on a movable carriage 413. The elongatetubular structure may comprise second movable portion 436 of thelinkage. The casing 410 may comprise the support 438 of the linkage. Thegear 433 remains connected to the elongate tubular structure 431 whenthe linkage is disassembled. The movables portion of the linkage 430 maycomprise gear 433, gear 434 and movable carriage 413 so as to advancethe elongate structure 431 distally when connected to the second movableportion 436 as shown with arrows 418. The cover 412 comprises flanges416. When the cover is placed on the casing, the elongate structure canbe locked into position 431 on the linkage.

The elongate element 310 comprises a spine 452 as described herein andis shown covered with a sheath 458. The sheath 458 comprises a channelto receive the elongate element 310. The elongate element 310 comprisesthe working channel and can inserted into the sheath 458 such that theelongate element is covered with sheath 458. The sheath 458 and elongateelement 310 are shown connected to manifold 468 as described herein.

The sheath 458 can be inserted into the patient prior to insertion ofelongate element 310. In many embodiments, sheath 458 is coupled tomanifold 468 when inserted into the patient.

The elongate element 310 is configured to slide into the sheath 458 suchthat the elongate element 310 and sheath comprise a lockedconfiguration. The elongate element 310 comprises structure 411configured to engage the housing 410 of the linkage, such that theelongate element 310 and housing 410 remain substantially fixed when theelongate structure 431 moves as described herein.

In many embodiments, casing 410 comprises support 438. The support 438may comprise a substantially non-moving portion of the linkage 430 asdescribed herein. The linkage 430 may comprise moving carriage 433 tomove the carrier 382 when the casing 410 comprising support 438 remainslocked to the arm and substantially non-moving as described herein.

In many embodiments, the structure 411 of the elongate element 310comprises locking structure to form a locked joint with the casing 410and cover 412.

In many embodiments, manifold 468 is connected to the sheath 458 and canbe affixed to the sheath to inset the sheath 458 into the patient andinflate the balloon anchor 24 with the manifold 468 as described herein.The elongate element 310 comprising spine 452 may then be inserted intosheath 458. The manifold 468 and structure 411 comprises lockingstructures 417 to lock the manifold to the elongate element 310 when theelongate element 310 has been inserted into the manifold 468 and sheath458. A release 415 can be pressed by the user to unlock the manifold 468from the elongate element 310.

The elongate tubular structure 431 of the linkage 430 comprisesstructures to receive the carrier tube 380. An opening 409 of theelongate tubular structure 431 is sized to receive the carrier tube 380.A connection structure 408 is shown on the proximal end of the linkage,and comprises a locking structure 406 to receive a protrusion 404 of theconnection structure 405 of carrier tube 308.

FIG. 14D1 shows rapid exchange of a carrier tube 380 when the linkage430 is coupled to the elongate element 310 anchored to a target locationof an organ. The elongate element 410 can be inserted or removed fromthe linkage by the user. The elongate element 380 can be advanced intoopening 409 near connection structure 405 of the elongate tubularstructure 431.

The imaging probe 460 can be mounted on a second linkage and configuredto move with the nozzle of carrier 382, so as to image interaction ofthe energy stream from carrier 382 when tissue is treated The images ofthe treatment may comprise axial images and sagittal images from theimaging probe 460. The linkage can be coupled to the controller orprocessor (or both) as described herein to move the imaging probe 460synchronously along the axis with the carrier 382 and nozzle of thecarrier, for example. The imaging probe 460 may comprise a trans-rectalultrasound probe and the carrier 482 may comprise a component of thetreatment probe 450 as described herein.

FIG. 14D2 shows alignment of the distal tip of the carrier 382 with theopening 409 of proximal end of the elongate tubular structure 431 toinsert the carrier tube 380 as in FIG. 14D1.

FIG. 14D3 shows the carrier advanced toward a locking structure 406 onthe proximal end of the linkage as in FIG. 14D1. The locking structure406 is sized to receive protrusion 404 so as to form a locked joint 402.

FIG. 14D4 shows the carrier tube 380 locked to the linkage 430 as inFIGS. 14D1 and 14D2. The protrusion 404 has been inserted into anopening of locking structure 406 so as to form the locked joint. Thejoint can be unlocked by user manipulation.

FIG. 14E shows a cytoscope inserted at least partially into a sheath 458for advancement toward an anchoring location of an organ. The anchoringlocation may comprise a bladder neck to view tissue of an organ such asthe prostate. The sheath 458 as described herein can be advanced to atarget location with visualization from the cytoscope placed within theworking channel of the elongate element 310. When positioned, the anchor24 such as a balloon can be inflated with a port of manifold 468 coupledto the sheath as described herein.

There are at least two forms of visualization possible with theembodiments as described herein. 1) The cystoscope is locked within thesheath 458. The purpose can be to view the prostate and then eventuallyleave the sheath as a safe channel to guide the elongate element 310comprising spine 452 into the patient, in many embodiments withouthaving direct visualization. The distal end of the sheath lines up nearbladder neck. 2.) Once the elongate element 310 is locked into thesheath 458, ureteroscope can be used to view the patient. Theureteroscope can be inserted inside the same channel that carrier 380goes into, for example shared channel.

FIG. 14F shows advancement of an elongate element 310 into a sheath 458.

The manifold 468 on the proximal end of the sheath 458 may comprise alocking structure to receive a locking structure on the proximal end ofelongate element 310. The elongate element 310 can be advanced intosheath 458 such that the locking elements on the sheath 458 and elongateelement 310 engage.

FIG. 14G shows a linkage 430 coupled to an elongate element 310comprising a spine 452. The linkage is configured to receive carrier 382and carrier tube 380 as described herein.

FIG. 14H shows a carrier tube and carrier inserted into the linkage tubein a locked configuration as described herein.

FIGS. 14A to 14H show a method of treating a patient in accordance withembodiments, and each of these figures shows one or more optional stepsof the method.

FIGS. 15 and 16 show self cleaning with a fluid jet as described herein.The fluid jet, for example fluid stream, as described herein, can beutilized to clean the working channel and clear tissue or other portswithin the multifunction sheath. The self cleaning can be automated orperformed manually. Additionally, water jet intensity can be reduced toclean laser cameras or other accessory devices without having to removethe devices from the working channel. For example an endoscope can besized to fit within the working channel or alternatively an endoscopecan be sized to fit within the working channel with the linkagedecoupled and to allow flushing and cleaning of the working channel.Alternatively or in combination the carrier 382 that may comprisecarrier tube 380 can be sized to fit within the working channelalongside an endoscope so as to allow cleaning of the endoscope.

In many embodiments the self cleaning can be employed with the probecomprising carrier 382 that may comprise carrier tube 380 positionedwithin the working channel. The elongated element 310 comprising thesheath and spine can contain the carrier 382 that may comprise carriertube 380 along a substantial portion of the carrier. The carrier 382 maycomprise a rectangular end portion or a tubular end portion and maycomprise a portion having a cylindrical and tubular geometry, forexample. The fluid stream released from carrier 382 can extend todistance 457 with divergence, for example. Alternatively the fluidstream may comprise a columnar fluid stream. An angle of the fluidstream 453 can be controlled with the linkage so as to rotate the fluidstream during cleaning. The fluid stream can be increased or decreasedin terms of pressure.

The fluid jet can be utilized to clean the working channel and cleartissue or other parts within the multifunction sheath. This can beautomated or performed manually. Additionally water jet intensity can bereduced to clean the laser camera or other accessory devices withouthaving to remove the devices from the working channel.

FIG. 17A shows components of user interface 500 on the display 425 ofthe system 400. The display 425 may comprise a touch screen display, forexample, alternatively or in combination, the display 425 can be coupledwith a pointing device, a keyboard, and other known user input devicesto work with processor systems. The interface 500 comprises an operationtab 502, a CO2 monitor tab 504, and a system configuration tab 506. Theuser interface 500 includes buttons 507 on the display to adjust up ordown values entered into the computer system. An abort button 503 isprovided on the user interface for the user to stop treatment of thepatient. A start button 501 is provided for the user to initiatetreatment of the patient. The user interface 500 comprises an image 510of an organ such as a prostate. The image 510 shown can be an image ofone or more of many organs as described herein. The image 510 maycomprise, for example, an image of a prostate from an anatomical imagecorresponding to a prostate of a patient. The image 510 is shown in anaxial transaxial cross-sectional view having an anterior and a posteriororientation, the image 510 is also shown along the longitudinal axis.The sagittal view of the image 510 along the longitudinal axis showsanchor 24 and a lumen such as the urethra. The image 510 may comprise animage of the patient to be treated, for example, an ultrasonic image ofthe patient. The image 510 can be shown in axial and sagittal views withthe ultrasonic image sized so as to correspond with the treatmentprofiles shown on the display 425.

A treatment profile 520 is shown in the axial and sagittal views. Thetreatment profile 520 corresponds to a profile of tissue to be removedin the surface remaining subsequent to removal. The treatment profile520 comprises a radius 522 extending from a central reference locationto an outer portion of the cut tissue boundary. The treatment profile520 comprises an outer component 524 extending circumferentially aroundan axis of the treatment. The treatment profile 520 extends from a firstend 526 proximate the bladder and the anchor to a second end 528 towardthe urethra. The treatment profile images shown on the display comprisea plurality of references to align the treatment with the anatomy of thepatient. An axis 530 corresponds to a central location of the treatmentand extends axially along a lumen of the patient such as the urethra.The treatment axis 530 may correspond to an anatomical reference of thepatient such as the urethra or path with which the instrument isintroduced to the patient. An angular reference 532 is shown extendingfrom the central axis of the treatment profile to an outer radialboundary of the treatment profile 534. The angular component 532corresponds to an anterior posterior location on the component of thepatient and extends from the anterior to the posterior to location 534to provide and permit alignment with the patient. As can be seen in thesagittal view, a treatment reference location 536 corresponds to alocation adjacent the inflatable anchor such as a balloon 24. Referencelocation 536 corresponding to the expandable anchor is shown alignedwith the end 526 of the treatment profile 20 in which the treatmentprofile is shown aligned with the axis 451 of the treatment probe.

The user interface 500 comprises a plurality of inputs. The plurality ofinput may comprise one or more of the following inputs as describedherein.

A plurality of angular input parameters 550 may comprise input 552 andinput 554, for example. The angular orientation can be set so as toalign with an anterior posterior direction of the patient extendingbetween axis 530 and marker 534. The input 552 can be used to adjust theangular orientation of the treatment around the axis 530, for example,when the patient and probe are aligned at slightly different angles. Aninput 552 aligns the center of the treatment profile in degreesrotationally around the axis. An input 554 provides a sweep angle fromone angular extreme to another, for example, a sweep angle may comprisean angle less than 360°, for example, 240°. The sweep angle generallyextends around the anterior-posterior treatment axis and extends fromthe anterior end treatment posterior treatment axis by a distance ofapproximately half the sweep angle, for example, sweeping 120° in thefirst direction and sweeping 120° in an opposite direction from theanterior posterior treatment axis. In many embodiments, the sweep angleis limited to less than 360 degrees to avoid sweeping the fluid streaminto the spine.

The angular position of the stream can be shown in real time on thedisplay with an output 556 of the angular position in degrees. Theoutput angle can be shown on the display as a moving colored line, forexample green, which sweeps around the axis 530. The position 566 canalso be shown on the display in millimeters and degrees.

A plurality of input parameters 560 can be used to determine the extentof the treatment along axis 451 and axis 530. An input 562 determines alocation of the treatment profile in relation to expandable anchor 24. Acontour checkbox 563 is shown on the display. An input 564 determines alength of treatment along axis 451 and axis 530. Input 564 may comprisea longitudinal distance of the treatment extending from a first end 524to a second end 528. An input 570 can determine a radius of thetreatment profile around axis 530. Input 570, a radial distance fromaxis 530 radially outward to an outer boundary of the treatment profile524. The radius may comprise a radial distance in millimeters such asthe distance of 10 mm for example. Alternatively, the radius can bedetermined with power of a pump which can be set with arbitrary valuesfrom 1 to 10, for example.

A select mode input 508 can allow the user to set the interface from acut mode to a coagulation mode, for example. In the cut mode, many ofthe inputs for the treatment can be provided so as to determine andalign the treatment with the patient. In the cut mode as shown the useris able to visualize the extent of treatment with respect to the anatomyof the patient and to formulate and improve treatment strategy. The usercan establish a cut profile having a predetermined profile surface and apredetermined removal volume.

The patient interface comprises additional outputs for the user todetermine appropriate treatment, for example, a time remaining in thetreatment can allow the user to determine the time of treatment and thetime remaining in the treatment, for example, an output 580 shows thetime remaining in seconds. An output 582 comprises an estimated volumeof tissue removal, the estimated volume of tissue removed can bedetermined based on the treatment profile. An estimated radial depth ofthe removal can also be determined and an output 584 can show theestimated radial depth of removal. The estimated depth of removal maycomprise the input radius from input 570 alternatively the estimateddepth may correspond to an estimated depth from a pump power of input570. A start button input 501 allows a user to start treatment when thephysician is satisfied with the patient treatment. When insufflation isused, for example insufflation with a gas such as CO2 an insufflationpressure can be set with an input 586. Alternatively, if liquid is usedas described herein as a second or first fluid in combination withanother liquid insufflation pressure may be set to zero or disabled. Inmany embodiments the insufflation may be set to zero in a first modesuch as the cut mode and set to an appropriate value in a second modesuch as the coagulation mode.

FIGS. 17B and 17C show a marker moving on a plurality of images in whichmovement of the marker corresponds to the position and orientation of anenergy stream. The energy steam may comprise a fluidic stream from thenozzle as described herein. A radial marker 557 is shown on the axialimage in relation to the resection profile 520. A longitudinal marker559 is shown on the sagittal image in relation to resection profile 520.The radial marker 557 is shown at a first angle in FIG. 17B and a secondangel in FIG. 17C so as to indicate the angle of the fluid stream fromthe carrier as described herein, for example. As the treatmentprogresses, the longitudinal maker 559 can move along the treatment axisof the sagittal image to indicate the longitudinal position of thenozzle on the carrier as the radial marker 557 sweeps rotationallyaround the axis on the axial image.

FIG. 17D shows a user defined resection profile 520. The user interfacecan be configured with instructions of the processor to allow the userto define a plurality of points of the treatment profile, andinterpolate among the points as described herein.

FIGS. 17E and 17F show a user interface to define a plurality of curvedportions of a cut profile. A first user movable input 551 can beconfigured to move along the display to define a first curved portion ofthe profile 520, and a second user movable input 553 can be configuredto move along the display to define a second curved portion of theprofile 520, and the instructions of the processor can be configured tointerpolate among the first curved portion and the second curved portionto define the profile 529 extending between the first curved portion andthe second curved portion, for example. A first end 526 of the treatmentprofile can be set based on user input and a second end 528 can be setbased on user input as described herein. The user can slide the firstmovable input 551 to determine the curved shape of the first portionbased on anchoring of the cut profile with the end 526 and the locationof the movable input 551 on the display. For example, the first curvedshape may be determined with a spline fit extending from the first inputto the end 526 constrained with angles at the end 526 and the movableinput 551. The second movable input 553 can be moved similarly to definethe second curved shape of the second portion, for example.

FIG. 18 shows a system configuration mode 506 for the cutting mode input508. When the system configuration is set the user can set severalparameters for the treatment prior to the treatment or during thetreatment so as to align the treatment profile with a patient and toinsure that the treatment probe 450 cuts tissue as intended. One or moreinputs 590 allows the user to align intended treatment with the probeplaced in the patient. One or more inputs 590 may comprise an input 591to zero the treatment and align the treatment axis with an axis of thepatient, for example the intended anterior posterior treatment profilecan be aligned in an anterior posterior direction of the patient suchthat an anterior posterior axis of the treatment profile is aligned withan anterior posterior axis of the patient. Input 591 can be set based onone or more measurements for example an ultrasonic imaging measurementto determine that the probe is properly aligned with the patient.Alternatively or in combination, input 591 can be set based on anglesensors as described herein. One or more inputs 590 may comprise aninput 592 to zero the treatment in the axially direction and align thetreatment probe with an intended anatomic target of the patient. Input592 allows alignment of the longitudinal axis with the intended targetlocation of the patient, for example if treatment probe 450 has beenplaced insufficiently far or too deep the zero z button can be pressedsuch that input 592 zeros the treatment at the correct anatomicallocation.

The system configuration mode can also be used to set and calibrate thesystem. For example, an input 598 can allow the zero angle of a firstangle sensor, for example, an angle sensor of the treatment probe 450 tobe set to zero and properly aligned. An input 599 can be used to set theimaging probe sensor to an appropriate angle, for example, to calibratethe imaging probe.

An input 595 can allow a user to select a probe type from among aplurality of probe types, for example the probe type may comprise aplurality of nozzle types, for example, a fourth nozzle type maycomprise a narrower nozzle diameter to allow treatment at a greaterdistance radially from the axis of the treatment probe 450. In thesystem configuration mode for a given profile a user can select aplurality of probe types so as to determine a time remaining, anestimated volume and an estimated depth based on the probe identifiedand, for example, the size of the nozzle of the probe selected.

By way of example, the input screens and parameters shown in FIGS. 17Aand 18 may refer to a divergent cutting screen in which a first fluidcomprises a liquid and the second fluid comprises a liquid.Alternatively a gas can be used to provide a protective jacket around atreatment beam in a treatment stream so as to extend the effectivecutting distance of the treatment probe 450. The system may compriseinstructions so as to perform a portion of the treatment with oneconfiguration of the first fluid and the second fluid and a secondconfiguration of the first fluid and second fluid so as to cut a secondportion of the treatment with a gas protecting the treatment stream.

In many embodiments in which the sweep angle is limited to less than 360degrees to avoid the spine as described herein, a first treatment can beperformed at a first angular orientation of the probe about the axis,the probe rotated to move the spine out of the way in order to exposethe untreated portion with the stream, and a second treatment performed.The angle of the probe for the first treatment can be measured, and theangle of the probe for the second treatment measured, and the treatmentrotated to treat the untreated portion based on the first and secondangles. For example, the first treatment may comprise a sweep of 240degrees, and the second treatment may comprise a sweep of 120 degrees,such that the total treatment extends substantially around the axis ofthe probe and to a greater angle than would be provided if the spinewere not rotated to expose the untreated portion. The probe may berotated to a second measured angle, for example 70 degrees, and thesecond treatment performed with a sweep of 120 degrees. The centerlocation can be adjusted with input 552 or software, such that thesecond treatment is aligned with the untreated portion.

FIG. 19 shows a coagulation mode selected with input 508. With theoperation tab selected with input 502, the treatment for coagulation canbe set. The coagulation can be provided in many ways, for example, witha divergent stream or a columnar stream and combinations thereof. Inmany embodiments it may be desirable to treat only a portion of thetreatment profile with coagulation. For example, a posterior portion ofan organ, for example, the prostate can be selectively treated withcoagulation. Work in relation to embodiments suggest that posteriortreatment may result in slightly more bleeding potentially and it can beadvantageous in some embodiments to selectively treat a posteriorportion of a patient's anatomy, for example, the prostate. In thecoagulation mode with a laser beam, the treatment input parameters aresimilar to those described above with respect to cutting. The sweepangle can be set with input 554, for example, to a value of 100° inwhich the sweep angle for coagulation is less than a sweep angle forcutting. The time of treatment remaining 580 can be shown and the usermay also see a volume of treatment, for example, a coagulation volume.The user is allowed to select laser power with an input 575 and also toposition the treatment similarly to what was done with the cutting andthe angular extent can be lesser and the longitudinal extent can belesser or greater, for example.

The input treatment profile can be input in one or more of many ways,for example, the image of the organ to be treated, for example, theprostate, can be provided and the user can draw an intended treatmentprofile on an axial view and a sagittal view of the patient. The imageshown may comprise an anatomical image corresponding to anatomy of ageneralized population or alternatively the images shown may compriseimages of the patient. The processor system comprises instructions tomap and transform the reference treatment profile on the image of thepatient to the machine coordinate references of the treatment probe 450and linkage 430 and anchor 24 as described herein. In many embodimentsthe images shown to the user are scaled to correspond to the treatmentprofile so that the treatment profile shown on the image of theanatomical organ treated corresponds to and aligns with the treatmentdimensions of the image. This allows the user to accurately determineand place the intended treatment profile on the patient.

FIG. 20A shows mapping and alignment of an image of the patient with thetreatment coordinate reference frame. The image 510 of the organ can beobtained in one or more of many ways as described herein. The image maycomprise an image reference frame, for example comprising X, Y and Zcoordinate references. The treatment probe 450 comprises a treatmentreference frame, for example cylindrical coordinate references R, Z,theta. The orientation of the axes of the probes can be determined asdescribed herein. A marker reference 536, such as the anchor of thetreatment probe can be identified from the image, in order to align thetwo images with a common known reference point. The points of the imagefrom the image reference frame can be mapped to the coordinate referenceframe and shown on the display, based on the location of the identifiedreference point and the orientation of the probes. A point in the imagehaving an image coordinate reference of (X1, Y1, Z1) can be mapped tothe treatment reference frame to provide treatment reference location(R1, Z1, T1). A three dimensional mapping of the patient tissue can besimilarly performed, for example.

Three dimensional mapping of the tissue of the target organ can beperformed, and the three dimensional mapping used to provide a threedimensional profile of the target organ. For example, a plurality ofsagittal views and plurality of axial views can be provided of the threedimensional profile of the organ, and the user can draw the targettreatment profile on each of the plurality of sagittal views and each ofthe plurality of axial views in order to provide a customized treatmentof the patient. In many embodiments, the processor comprisesinstructions to interpolate the treatment profile among the sagittal anaxial views, so as to provide a mapped three dimensional treatmentprofile. In many embodiments, providing additional treatment of theprostate medially may provide additional tissue removal, and the mappingas described herein can be used to provide additional removal of medialportions of the prostate tissue.

In many embodiments, the user can identify a plurality of points of atreatment profile on the image of the tissue of the patient, and theplurality of points are mapped to the treatment coordinate reference,and shown on the display so that the user can verify that the treatmentcoordinates of the treatment profile shown on the display treat thetargeted tissue as intended by the user.

FIG. 20B shows a method 600 of treating a patient.

At a step 602, a calibrated treatment probe as described herein isprovided.

At a step 605, an image of an organ (e.g. prostate) as described hereinis provided.

At a step 607, a reference structure of a treatment probe as describedherein is provided.

At a step 610, the reference structure is aligned with the image of theorgan as described herein.

At a step 612, organ image coordinates are mapped to treatment referencecoordinates as described herein.

At a step 615, image coordinates are scaled to match treatment referencecoordinates as described herein.

At a step 617, images of the organ aligned with reference structure aredisplayed as described herein.

At a step 620, treatment input parameters are received as describedherein.

At a step 622, the tissue resection profile is determined based on theinput parameters as described herein.

At a step 625, the tissue resection profile is displayed on views of theorgan as described herein.

At a step 627, the tissue resection profile and location are adjustedbased on the images as described herein.

At a step 630, resection parameters are determined as described herein.

At a step 632, a treatment nozzle is identified from among a pluralityof treatment nozzles as described herein.

At a step 633, a carrier is identified from among a plurality ofcarriers as described herein.

At a step 635, a fluid stream type is selected as columnar or divergentas described herein.

At a step 637, a first fluid and a second fluid are selected asdescribed herein.

At a step 640, a treatment probe is inserted into the patient asdescribed herein.

At a step 642, a treatment probe arm is locked as described herein.

At a step 645, an imaging probe is inserted into the patient asdescribed herein.

At a step 650, an imaging probe is locked as described herein.

At a step 657, an imaging probe is moved in relation to the treatmentprobe as described herein.

At a step 660, alignment of the treatment probe with the patient isdetermined as described herein.

At a step 662, orientation of treatment probe is measured as describedherein.

At a step 665, orientation of a treatment probe is measured as describedherein.

At a step 667, the planned treatment is adjusted based on patientalignment as described herein.

At a step 668, the patient is treated as described herein.

At a step 670, tissue treated with the planned treatment is imaged andviewed as described herein.

At a step 672, the jet entrainment “fluid flame” is viewed as describedherein.

At a step 675, interaction of the jet entrainment “fluid flame” isviewed as described herein.

At a step 677, additional tissue is resected based on the viewed imagesas described herein.

At a step 680, treatment is adjusted as described herein.

At a step 682, the elongate element and sheath are rotated amount theelongate axis to rotate the spine as described herein.

At a step 685, an angle of rotation of the elongate element and spineare measured as described herein.

At a step 687, the treatment profile is rotated around the axis based onmeasured angle. For example, the treatment profile can be rotate aroundthe elongate axis of the treatment profile corresponding to the elongateaxis of the elongate element and spine and sheath as described herein asdescribed herein.

At a step 690, a portion of the organ blocked as described herein by thespine is treated.

At a step 695, treatment is completed as described herein.

Although the above steps show method 600 of treating a patient inaccordance with embodiments, a person of ordinary skill in the art willrecognize many variations based on the teaching described herein. Thesteps may be completed in a different order. Steps may be added ordeleted. Some of the steps may comprise sub-steps. Many of the steps maybe repeated as often as if beneficial to the treatment.

One or more of the steps of the method 600 may be performed with thecircuitry as described herein, for example one or more of the processoror logic circuitry such as the programmable array logic for fieldprogrammable gate array. The circuitry may be programmed to provide oneor more of the steps of method 600, and the program may comprise programinstructions stored on a computer readable memory or programmed steps ofthe logic circuitry such as the programmable array logic or the fieldprogrammable gate array, for example.

FIGS. 21A and 21B show screenshots of organ images, for exampletrans-rectal ultrasound prostate images, from 3D segmentation softwareaccording to embodiments of the present invention. The two dimensionalimages shown on the right side of FIGS. 21A and 21B, respectively. Threedimensional images of the prostate are shown on the right left of FIGS.21A and 21B, respectively. The two dimensional images on the right sideof FIGS. 21A and 21B show examples of transverse and sagittal planes,respectively, of the three dimensional prostate representations shownwith the images on the left of FIGS. 21A and 21B. The transverse imagemay also be referred to as horizontal image, axial image, or transaxialimage as described herein. Note segmentation of the sagittal plane ofthe prostate is depicted in light gray color, and the segmentation ofthe axial plane of the prostate is depicted in light gray color.

These segmented images can be provided on the display for the user toplan the treatment of the organ with images of treatment overlaid on theimage of the organ as described herein, such as the treatment profilesoverlaid on the image of the prostate.

The images shown in FIGS. 21A and 21B can be provided on the display 425of interface 500. For example the axial and sagittal images can beprovided on the display as described herein.

FIGS. 21C to 21F show a plurality of axial images 525 of a target tissueto define a three dimensional treatment plan and a user definedtreatment profile in each of the plurality of images. The user interfacecomprises a first tab 527 to select a Z-slice view and a second tab 529to select a Y-view, of a three dimensional representation of a targettissue such as an organ that may comprise the prostate. The Z-slice viewmay correspond to a sagittal image of the target tissue and the Y-sliceview may correspond to an axial view of the target tissue. The pluralityof axial images comprises a first image 525A at a first z-frame 523. Thez-frame 523 may correspond to a location along an axis of the traversedby the y-slice view, and each z-frame may correspond to a location ofthe axial image along the z-axis. The first z-frame can be one or moreof many frames.

Each image 510 comprises a user input treatment profile 520. The userinput treatment profile may comprise a plurality of points that are useradjustable on the image to define the treatment profile. The firstplurality of images 525A shows the treatment profile partiallypositioned by the user, and a plurality of treatment profile markerpoints 521 have yet to be placed on the target tissue location by theuser. The user can adjust the location of the points with the userinterface, for example with a pointing device or touch screen display.The processor as described herein comprises instructions to receive theplurality of points input by the user. The plurality of points maycomprise small user movable markers such as circles, dots or X's, andthe plurality of points can be connected with lines in one or more ofmany ways, such as with a linear interpolation corresponding to straightlines on the display or splines corresponding to curved lines shown onthe display so as to connect the markers, for example.

A second image 525B of the plurality of images at a second depth isshown on the display as described herein. The second image 525Bcomprises points 521 aligned with the image by the user so as to definethe treatment profile 520 at the second location along the z-axiscorresponding to the treatment.

A third image 525C of the plurality of images at a third depth is shownon the display as described herein. The third image 525C comprisespoints 521 aligned with the image by the user so as to define thetreatment profile 520 at the third location along the z-axiscorresponding to the treatment.

A fourth image 525D of the plurality of images at a fourth depth isshown on the display as described herein. The fourth image 525Ccomprises points 521 aligned with the image by the user so as to definethe treatment profile 520 at the fourth location along the z-axiscorresponding to the treatment.

FIG. 21G shows a sagittal view of the target tissue and planes of theaxial images of FIGS. 21C to 21F. The z-slice view can be selected withtab 527, so as to show a sagittal view of the target tissue. Theplurality of images 525 are shown as lines extending through thesagittal view.

FIG. 21H shows a three dimensional treatment profile based on theplurality of images of FIGS. 21A to 21F. The three dimensional treatmentplan may comprise a three dimensional representation of the threedimensional treatment profile 520. The three dimensional treatmentprofile 520 can be determined in one or more of many ways. The threedimensional treatment profile may be obtained by interpolation among theplurality of points 521 that define the treatment profile of each image,for example by linear interpolation of splines. Alternatively or incombination, the three dimensional treatment profile can be determinedbased on polynomial fitting to the surface points 521, for example.

FIG. 21I shows a user input treatment profile of an image among aplurality of images as described herein. The user can adjust theplurality of points 521 in one or more of many ways, and the user candetermine the treatment profile based on patient need. The treatmentprofile can be selected so as not to extend to an outer boundary of atissue structure, for example an outer structure of an organ such as aprostate as shown in FIG. 21I.

FIG. 21J shows scan patterns 840 of the fluid stream as describedherein. The fluid stream may comprise a pulsed or continuous fluidstream. The scan pattern can be based on critical pressures as describedherein so as to remove a first tissue and inhibit removal of a secondtissue. In many embodiments, the fluid stream comprises a plurality ofpulses 810 from a pump such as a piston pump, and the pulses comprise afrequency and duty cycle. In many embodiments, the duty cyclecorresponds to no more than about 50%. The plurality of pulses 810comprises a first pulse 812 and a second pulse 814. The fluid flame maycomprise an approximate cross sectional size at the location of tissuebeing scanned. Based on the teachings described herein, a person ofordinary skill in the art will recognize that the fluid flame comprisesa maximum cross sectional width at about ½ the length of the fluidflame. At the location where the fluid flame impinges upon tissue, thefluid flame comprises a cross sectional size 848.

The scanning pattern of the fluid stream comprising the fluid flame arealong a Z-axis 842 and angle 844. The angle 844 may correspond to time845, for example when the angular sweep rate remains substantiallyconstant. The fluid flame is scanned along a scan path 846. The scanpath 846 may correspond to the velocity of the carrier 382 along theZ-axis and the rotation of the carrier 382 around the Z-axis, forexample.

The pulses can be spaced apart such that a plurality of sequentialpulses strike a location 830 of tissue. The plurality of sequentialpulses can be effective in removing a first type of tissue when removalof a second type of tissue is inhibited.

Alternatively or in combination with the critical pressures as describedherein, work in relation to embodiments suggests that the rate ofremoval can be related to a relaxation time of a targeted tissue. Thefluid flame can be configured to dwell on a point 830 of tissue for aduration longer than the relaxation time of the tissue, such that thetissue can be deformed beyond a threshold and removed.

In many embodiments, the plurality of pulses 820 impinge upon the tissuelocation 830 with a duration between pulses 822, 824 that is less than atissue relaxation time of elastic deformation of the tissue so as toremove the tissue. In many embodiments, a first tissue to be removedcomprises a first relaxation time greater than the time between pulses,and the second tissue for which removal is to be inhibited comprises asecond tissue relaxation time less than the time between pulses, so asto inhibit removal of the second tissue.

As the tissue is removed toward the final desired treatment profile, thesize of the fluid flame may decrease substantially near the distal tipof the flame, such that the size of the pulsed fluid flame impingingupon the resected profile is decreased substantially tissue removaldecreased substantially.

Based on the teachings described herein, a person of ordinary skill inthe art can determine the scanning movement of the carrier 382 andnozzle to resect tissue to a target profile with the fluid flame asdescribed herein.

FIG. 21K shows a bag over a fluid stream. The fluid stream may comprisethe columnar stream or divergent stream as described herein. In manyembodiments the bag is placed over a fluid stream comprising a pulsedstream so as to comprise a water hammer. The bag can be made of one ormore of many materials and may comprise an elastomer, for example. Theinterior of the bag can be coupled to the carrier 382, and the exteriorof the bag can be coupled to the working channel to remove material. Thebag has the advantage of protecting the tissue from the high fluid flowrate and can provide more even pressure. The fragmented tissue can becollect through passive or active means, for example through an outercollection tube or the working channel.

FIGS. 22A and 22B show schematic illustrations of a probe being operatedin accordance with the principles of embodiments as described herein, soas to provide a real time determination of the tissue removal profile520. FIG. 22A shows columnar fluid stream 331 and FIG. 22B showsdiverging stream 334, each of which is suitable for combination with theimage guided tissue resection as described herein.

Interstitial laser-guided 3D imaging (inside tissue and/or inside anorgan with or without fluid and with or without a water jet): employ thespot from the laser on the inner surface of the prostate to determinethe depth of a cut. That is, knowing the axial and rotational positionof the nozzle, and given that the spot lies on a radius from the nozzle,locating the spot in the image from the camera gives a uniquespot-to-nozzle distance. Scanning the laser, and using image processingto find the spot, a full image of the volume inside the prostate can beproduced. Combining this with the organ geometrical data, the volumeresected can be displayed within the organ in 3D. Alternatively, usingthe laser to measure the distance between itself and the target surface,an exact three-dimensional replica of the area it has scanned can berecreated.

Acoustic distance measurement.

By placing an acoustic transducer in the assembly near the water jet itwill be possible to measure distance along the water jet to the tissueplane struck by the jet. Scanning the jet then allows three-dimensionalmapping of the cavity. At least one transducer 392 can be provided onthe carrier tube 380. Interstitial sound-guided tissue differentiation(inside tissue and/or inside an organ in fluid/gas environments): theaudible frequencies produced by the jet-tissue interface can allow fordifferentiation of tissue. Monitoring the acoustic behavior at thisinterface may add a depth monitoring feature to the system; this canenhance safety as to prevent the jet from penetrating the prostate'scapsule. The sensor could be attached to the tip or anywhere along theprobe/sheath's shaft.

Pulse width modulation of the water column: modulating the frequency atwhich the water is on and off can allow the user to estimate thedistance of nozzle to tissue under camera visualization. The frequencycan be fixed to a predetermined column size (e.g. 5 mm) or user couldadjust it to match the height between the nozzle and tissue, as shown inFIG. 22A. Alternatively, the diameter of the jet at the jet-tissueinterface can determine distance from nozzle assuming the high pressuredivergence characteristics of the nozzle is defined as shown in FIG.22B.

The at least one transducer 392 may comprise an acoustic transducer toreceive acoustic signals from the tissue. In some embodiments, at leastone transducer 392 transmits acoustic signals for ultrasound imaging.The at least one transducer may comprise a plurality of transducers. Asecond acoustic transducer can be provided on carrier tube 380 to one ormore of receive or transmit acoustic signals for ultrasound imaging fromthe probe to the tissue. The at least one transducer 392 may comprise anultrasound array to provide axial and transverse imaging as describedherein, for example.

FIG. 22C shows an endoscope 394 placed in the working channel ofelongate element 310 with carrier 382 to image tissue. The endoscope 394can be used to image the tissue profile as described herein. Forexample, a fluid stream can be used to illuminate the tissue with laserpointing with the fluid stream, for example columnar fluid stream 331.The known angle and axial location of the fluid stream can be used withthe location of the image from the endoscope to determine the surfaceprofile of the tissue.

FIGS. 23A and 23B show a carrier configured to provide integrated jetdelivery. The carrier 382 that may comprise carrier tube 380 comprisesan energy delivery conduit 351, such as an optical fiber. An alignmentblock is provided to align the optical fiber with the fluid deliveryelement. The optical fiber can be bent to provide a bend angle suitablefor delivery of optical energy to the end of the optical fiber.

The configuration of the optical fiber, jet orifice and alignmentorifice provide the integrated jet capability. The jet orifice can beformed in a nozzle that comprises an inverted solid conic section thatdefines a conic channel to receive the fluid to form the fluid streamand to receive light from the optical fiber. The alignment orifice canbe formed in an alignment structure and comprises an inverted solidconic section that defines a conic channel to receive the fiber and theconic channel extends to a cylindrical channel having a diameter sizedto receive the optical fiber. In many embodiments, the conic channelcomprises of the alignment orifice comprises an angle to receive thefiber such that the fiber can be advanced along the conic channel andthrough the cylindrical channel without damaging the optical fiber. Inmany embodiments, the optical fiber, including the cladding, comprises adiameter less than the cylindrical channel of the alignment orifice,such that the optical fiber can be advanced along the cylindricalsection without damaging the fiber. The flat section of the alignmentblock can hold the fiber to inhibit movement of the fiber along thelongitudinal axis of the fiber when the tip of the fiber is held inalignment with the cylindrical portion of the jet orifice channel.

The nozzle comprising the jet orifice and the alignment structurecomprising the alignment orifice may each comprise a jewel having theconic section and cylindrical section as described herein.

In many embodiments, the cylindrical channel portion of the alignmentorifice holds the optical fiber in alignment with a gap extending aroundat least a portion of the optical fiber. The cylindrical channel portionof the alignment orifice extends along an axis a sufficient distance soas to align the optical fiber with the jet orifice with the gapextending between the fiber and the cylindrical channel portion of thealignment orifice along at least a portion of the fiber and thecylindrical channel portion.

The jet orifice and alignment orifice are spaced apart axially asufficient distance such that the fluid that passes through the jetorifice can deliver a fluidic stream of energy with predictable flow,for example so as to form the columnar stream with low pressure and thedivergent cutting stream with high pressure. In many embodiments, adistance 351D extends between an upper surface of the structure definingthe cylindrical channel portion of the alignment orifice and the lowerend of the cylindrical channel of the jet orifice. Distance 351D isdimensioned such that the light beam emitted from the optical fiberdiverges so as to allow energy transmission of at least about 80%through the jet orifice, for example at least about 90% through thealignment orifice, and such that the predictable flow can be provided.In many embodiments, the distance 351D is within a range from about 200um to about 2.5 mm, for example within a range from about 0.5 mm toabout 2 mm, for example.

An alignment block is coupled to the optical fiber, and the alignmentblock comprises a surface to engage the optical fiber in which the fiberengaging surface comprises a radius of curvature which can be less than5 mm, for example no more than 2 mm, so as to allow the cross sectionaldimensions of the tip of the carrier 382 to be sized to pass through theworking channel with rapid exchange as described herein.

The alignment block can engage the optical fiber so as to retain theoptical fiber. The curved engagement surface of the alignment blockengages the optical fiber and retains the optical fiber in position. Thelower engagement surface of the block also comprises a substantiallynon-curved elongate channel portion proximal to the curved portion toengage the fiber and fix the location of the fiber within the probe, forexample by holding the fiber between the block and an upper surface ofthe lower portion of the carrier 382.

The fluid jet can be used at high pressure for ablation, for example, afluid jet, or low pressure, for example, columnar for transmitting anoptical beam. The optical fiber can be bent, guided and aligned bypositioning the alignment block and alignment orifice to achieve adesired alignment. A short and tight bend radius can be achieved bypositioning and fixing the optical fiber in this manner. Cavitation andother fluid jet effects can be altered by varying the relative positionand orientation of the jet alignment orifices.

The fluid stream released from the fluid delivery element may comprise adiverging stream 334 as shown in FIG. 23A or a columnar stream 333 asshown in FIG. 23B. The diverging stream 334 can be provided by providinga higher pressure to the delivery element. At high pressure the fluidjet will diverge, for example when the first fluid is a liquid and thesecond fluid is a liquid. Alternatively a low pressure can be providedto provide the columnar stream 333 as shown. The columnar stream 333 canbe provided when the fluid released is a liquid and the liquid isreleased into a gas, and the liquid can be released with a low pressurewithin a range from 2 to 100 psi, for example within a range from 5 to25 psi. At the low pressure the columnar fluid comprising the columnarstream 333 can be used as a pointing device to point the laser beam foralignment. Alternatively or in combination the columnar fluid stream canbe used to heat tissue, for example, to heat with one or more ofablation, vaporization, or coagulation, for example.

The diverging stream 334 can be provided by increasing the pressure tothe nozzle for tissue removal with the divergent stream as describedherein. The optical fiber of the carrier 382 that may comprise carriertube 380 can be bent to provide a narrow profile configuration of thecarrier 382. For example, the optical fiber can be bent with a radiuswithin a range from about 1 to 10 mm, for example, within a range fromabout 2 to 5 mm. This bending of the optical fiber can allow the lightenergy to be released and transmitted with high efficiency from a lightsource to the desired tissue target. Also the terminal end of theoptical fiber can be aligned such that light emitted from the opticalfiber is substantially directed through the channel defined with thenozzle that delivers the fluid stream. An alignment structure comprisingan alignment orifice can be used to align the optical fiber with the jetorifice of the fluid delivery element.

FIG. 24 shows carrier 382 comprising a fluid delivery element and designconsiderations of the fluid delivery element. The jet orifice design ofthe fluid delivery element can be configured in one or more of manyways. Fluid jet ablation characteristics can be varied by varying thejet orifice geometry. For example cone angle variation will result in anincrease or decrease in cavitation occurring at the nozzle exit. The jetorifice design may comprise a cone at one or more of the entrance or theexit of the orifice. The cone angle can vary from 0 to 180 degrees, forexample. The orifice diameter and orifice length variation can result ina variation in nozzle back pressure and exit speed of the fluid stream.The resulting entrainment region varies with each of these parameters.The entrainment region may comprise a cloud of cavitation bubblesgenerated by the nozzle. The depth of tissue penetration can bepredicted and controlled based on the entrainment region length. In manyembodiments the entrainment region can be visualized with ultrasoundimaging or optical imaging in combinations thereof. The entrainmentregion corresponds to a region where cavitation occurs, which allows theentrainment region to be visualized and can be referred to as a fluidflame. The cool cutting of the entrainment region can allow for tissueremoval with minimal tissue damage. In many embodiments the cone angleswithin a range from about 40 degrees to about 80 degrees. A ratio of theorifice length to the inner diameter of the orifice can be within arange from about 1 to 10, for example, within a range from about 4 to 7.A person of ordinary skill in the art can design a jet orifice to treattissue as described herein based on the teachings provided herein.

FIGS. 25A through 25C show jet deflection in accordance withembodiments.

A deflector 710 can be provided on the distal end of carrier 382. Thejet deflection can be achieved in one or more of many ways. The fluidjet can be deflected to achieve different cutting angles, for example.Alternatively or in combination, deflected or diverted fluid jets can beutilized to clean the working channel and auxiliary devices, forexample. Deflection of the fluid stream can be actuated manually orrobotically via pull wires, pneumatics, hydraulics, mechanical links andother means, for example. The deflector can be moveable under computercontrol and the deflector may comprise a gimbal to vary deflection ofthe fluid stream with respect to the longitudinal axis of the carrier382. FIG. 25A shows deflection of the fluid stream to a first angle inrelation to the longitudinal axis. And FIG. 25B shows deflection of thefluid stream at a second angle to the longitudinal axis. FIG. 25C showsrotation of the fluid stream around the longitudinal axis with the fluidstream deflected at the second angle.

FIGS. 26A through 26C show jet masking in accordance with embodiments.

Fluid jet masking can be used to achieve different cutting areas, forexample in a single location or multiple locations. A masking mechanismcan be actuated manually or by robotically via pull wires, pneumatics,hydraulics, mechanical links and other means, for example. In manyembodiments a hypo tube extends along carrier 382 so as to allow shapingof the mask on the distal end of the carrier 382. A mask 720 comprises afirst configuration 722 as shown in FIG. 26A. As shown in FIG. 26B, mask720 comprises a second configuration 724 in which the mask has beenadjusted to provide a wider angle of the release fluid stream. FIG. 26Cshows a third configuration 726 of the mask.

The mask embodiments as described herein can allow rotation of the maskaround the longitudinal axis for angles of rotation greater than 360degrees. For example, a plurality of rotations can be used. Theplurality of mask configurations can allow sculpting of the targettissue to a desired intended profile and can allow rapid removal of thetissue with sweep rates that allow a smooth profile to be provided. Theshape of the mask can allow for bulk tissue removal with a largedivergence angle for tissue proximate to the mask. For tissue fartherfrom the mask the angle may be decreased so as to provide decreaseddivergence of the jet to reach tissue at a location farther from themask.

FIGS. 27A and 27B show variation of jet angle in accordance withembodiments. The fluid jet angle and the laser beam can be fixed atdifferent angles to achieve cutting or coagulation. The one or more ofcutting or coagulation can be directed to a single location or multiplelocations, for example. Angling can assist in targeting tissue near anexpandable anchor such as a balloon or reduce risk of incidental contactwith unintended tissue. The jet angle can be varied in one or more ofmany ways. For example, a plurality of carriers 730 can be provided, andeach of the carriers may comprise carrier 382 having structures andcomponents for treatment as described herein. Each of the plurality ofcarriers 730 can provide a different fluid stream angle. For example, afirst carrier can provide a first angle 732. A second carrier canprovide a second jet along the second angle 734 and a third carrier canprovide a third angle 736 as shown. The plurality of probes may comprisea set of probes, for example, three or more probes in which each probeis configured to direct one or more of the jet angle or the laser beamat an angle. For example, first angle 732 can extend substantiallyperpendicular to the elongate axis and third angle 736 can be directedtoward a distal end of the probe in order to resect medial tissue, forexample tissue of the prostate.

In many embodiments, a plurality of probes can be provided in which oneor more jets exits the device axially to target tissue immediatelydistal of the device.

FIG. 28 shows a plurality of jets delivered simultaneously in accordancewith embodiments. The plurality of jets of carrier 382 may comprise aprimary jet 740 and a secondary jet 744 connected with the supplychannel 742. The supply channel 742 may comprise a common supplychannel.

Multiple jets can be employed to achieve concurrent ablation andcoagulation. This can be achieved through the use of a single supplychannel or multiple supply channels. In the case of a single supplychannel, a small amount of pressure can be bled off to feed thesecondary jet. Additionally, a low power source laser pointer can beutilized for the secondary jet to assist in tissue targeting while usingthe primary jet for ablation.

In many embodiments, the secondary jet can be used to direct a lightbeam to coagulate tissue and the primary jet can be used to clear tissueaway while the secondary jet is utilized as a wave guide.

In many embodiments, the primary jet can be used to debride tissue whilesecondary jet is used to coagulate tissue.

FIG. 29 shows morcellation in accordance with embodiments. In manyembodiments, morcellation can be achieved concurrently with ablationwith structural features 750 such as blades on the probe or spine forexample. If integrated to the probe, morcellation can be automaticallydriven by the movement of the probe. Vacuum suction can be usedalongside or independently with physical morcellation to increasecollection flow. The combination of physical morcellation for examplewith an auger structure and vacuum can be utilized to regulateintraorgan pressure.

Carrier 382 can extend to a distal end portion having one or more jetsas described herein. Morcellating features can be provided proximatelywith respect to the jets and the morcellating features may be containedwithin the working channel, for example, with an auger shaped structureto remove tissue.

FIG. 30 shows a single tube design in accordance with embodiments. Thesingle tube design may comprise a fluid delivery element such as anorifice jewel 762. A variable bend 760 allows a radius to bend, forexample, when the carrier 382 is advanced within the working channels. Afluid is coupled to the orifice on the end of the carrier 382. The fluidmay comprise liquid or gas and the orifice on the distal end can beconfigured in one or more of many ways as described herein. FIGS. 31Aand 31B show a single tube design in accordance with embodiments. Afluid such as a liquid or gas can be coupled with a laser as describedherein. The laser can emit electromagnetic energy transmitted along anenergy conduit 351 such as an optical fiber as described herein. Avariable bend 760 can be provided near the fluid delivery element suchas an orifice jewel 762 on the distal end. The optical fiber can bealigned with structures as shown in FIG. 31B. For example, a fiber guide764 can be used to locate the optical fiber coaxially with the orificeof the fluid jet.

The single tube design in accordance with the embodiments of FIGS. 30,31A and 31B can provide many advantages. For example, package size andcomplexity can be greatly reduced when utilizing a single tube design.Internal laminar flow characteristics can be improved with a single tubedesign as the fluid path can be more continuous than with other designs,for example. The orifice jewel can be swaged in place or a small covercan be laser welded to retain the jewel. Optical fiber integration canbe achieved through the use of an internal fiber alignment structure.The bend angle and radius can be varied so as to allow for alternatetissue targeting or for manufacturing. Multiple jets can be employed tobalance jet reaction courses and cut more than one locationconcurrently. For example, opposing jets can be used. An additional jetmay be added to power rotational motion of the catheter for example.

The small package size can allow the implementation to take the form ofa small catheter. This can allow for use with prior commerciallyavailable rigid and flexible introducers and scopes. The distal tipshapes can be preformed with a given bend angle to access a tissuevolume.

FIG. 32 shows means of registering and locating the treatment systemwith respect to the human anatomy in accordance with embodiments. Aplurality of expandable anchor 770 comprises a first expandable anchor772 and a second expandable anchor 774. The first expandable anchor 772may comprise a balloon, for example, and the second expandable anchor774 may comprise a second balloon, for example. The first expandablestructure can be configured to expand in the bladder neck, and thesecond expandable structure can be configured to expand within theurethra so as to contain movement of the device.

FIG. 33 shows a plurality of expandable structures comprising a firstexpandable basket 776 and a second expandable basket 778. The expandablebasket can be permeable or nonpermeable and can be expanded to allowanchoring. The nonpermeable basket can inhibit fluid flow through theurethra, while the permeable expandable basket can allow fluid flowthrough the urethra and between the urethra and the bladder.

The plurality of expandable structures can have the benefit of limitingmovement of the probe, both from the bladder toward the urethra and alsomovement from the urethra toward the bladder neck, so as to effectivelylock the anchor in place.

FIG. 34 shows means of registering the system with respect to the humananatomy. For example, a plurality of expandable anchors 770 may comprisea first expandable anchor 777 and a second expandable anchor 779. Thefirst expandable anchor 777 may comprise a balloon or a basket, forexample. The expandable anchor 777 is used to position against aposterior wall of the bladder. The second expandable anchor ispositioned in the bladder neck. The first expandable anchor and thesecond expandable anchor can lock the position of the probe so as toinhibit movement. Opposing forces can be applied manually or via roboticcontrol.

In some embodiments, an opposing force can be applied between the firstexpandable anchor and the second expandable anchor, so as to urge thefirst expandable anchor toward the bladder wall and the secondexpandable anchor toward the neck of the bladder.

Additional anchoring op embodiments can be provided in accordance withthe teachings described herein. For example, a suction means can be usedfor anchoring. Alternatively, sensors for patient movement can be used.An arm can be used for anchoring. Clamps can be provided on the groinfor anchoring. Magnetic forces can be used to hold the system in place.An attachment to tissue can be provided with suction. Each of theseprovide nonlimiting examples of anchoring means in accordance with theembodiments described herein.

FIG. 35 shows a disposable balloon in accordance with embodiments. Thedisposable balloon 780 can be threaded onto a distal end of the carrier382. The disposable balloon may comprise internal threads in the tip ofthe balloon. Internal thread 782 can engage external thread 784.Threaded engagement between the balloon and the carrier can allow theballoon to be removed subsequent to treatment and the carrier 382 can besterilized. An inflation hole can be provided. The inflation hole 786allows inflation of the balloon 780 when the balloon 780 has beenthreadedly engaged on the distal tip. The disposable balloon can besterilized individually. The threaded attachment of the balloon can beprovided to a hand piece or to the carrier as described herein. Sealingcan be achieved with the O-rings 788 and threaded engagement. A ballooncapable of achieving a 1 to 7 collapsed to inflated ratio can beprovided.

FIG. 36 shows tissue resection and depth control in accordance withembodiments. A live patient ultrasound image is shown. FIG. 37 shows avisible fluid flame in saline. The visible fluid flame in salinecorresponds to the entrainment region of the jet as described herein.The visibility of the fluid flame of the entrainment region is providedwith cavitation of small bubbles that can produce light scattering oracoustic scattering, so as to make the fluid flame of the entrainmentregion visible with imaging by ultrasound or optical imaging, forexample. The benefit of the visible entrainment region can be for aphysician to visualize the distance of the treatment and to compare thisdistance with ultrasound. FIG. 37 shows the visible entrainment regionat 11 millimeters, the same size as is shown in FIG. 36. The substantialsimilarity of the distance of the entrainment region corresponds to thedistance of tissue resection and removal. This experimental resultshowing the visualization of the entrainment region can provide for asafer treatment. Merely by way of example, the flow parameters used withthe images shown in FIGS. 36 and 37 comprise a flow rate ofapproximately 130 milliliters per minute and a nozzle back pressure ofapproximately 2700 psi. The configuration of the nozzle on the carriercomprise a first liquid emitted with a divergent stream as describedherein into a second fluid so as to provide the divergent stream. Thesecond fluid comprises a liquid.

A physician when treating a patient, can use a live patient ultrasounds,for example, transrectal ultrasound (hereinafter “TRUS”) as describedherein. The physician can do the ultrasound in the entrainment regionfrom the probe tip. This can be used to determine the appropriateparameters to treat the patient. For example, the physician can adjustthe pressure so as to limit the depth of penetration of the probe tipsuch that the probe tip does not release energy to cause cutting outsideof the organ, for example, beyond the sack of the organ such as the sackof the prostate. The image of FIG. 36 shows on the left hand side of theimage a structure corresponding to an expandable balloon and the arrowsshow the 11 millimeter dimension. FIG. 37 is an optical image showing asimilar distance of the entrainment region. The sweeping motion of thestream shown in FIG. 36 can be used to adjust the treatment to becontained within the prostate.

FIG. 38 shows tissue resection depth control in accordance withembodiments. Live patient ultrasound from the patient is shown in FIG.38 similar to FIG. 37, but with increased back stream pressure to thenozzle.

FIG. 39 shows an optical image of the fluid flame in saline showing theentrainment region with a different pressure. The pressure flowparameters for FIGS. 38 and 39 comprise an approximate flow rate of 205milliliters per minute and the nozzle back pressure of approximately5760 psi. The corresponding tissue resection depth is approximately 16millimeters. The live patient ultrasound image shows an entrainmentregion of 16 millimeters similar to the entrainment region seenoptically. The sweeping motion of the probe and the fluid stream emittedfrom the probe as seen on the left hand side of the image can be used toset the flow parameters and pressure so as to treat the patient safelywith ultrasound images of the entrainment region.

FIG. 40 shows nozzle flow rate versus maximum penetration depth for aplurality of pressures and nozzles. The flow rate in milliliters perminute is shown. The maximum penetration depth is also shown as afunction of the flow rate. 130 micron nozzle shows a tissue penetrationdepth with diamonds and the 150 micron nozzle is shown with X's. Thetissue penetration depth can be used based on the teachings describedherein to set the flow rate parameters for treatment. For example, for atreatment to a maximum penetration depth of 12 millimeters or 130micrometer nozzle, a flow rate of 150 milliliters per minute isselected. Similarly, for the 150 micron nozzle, a flow rate of 200milliliters per minute is selected. A person of ordinary skill in theart can construct software to automatically identify a nozzle fortreatment based on depth and also to identify a flow rate suitable fortreatment based on depth. In addition, the flow rate can be varied basedon the tissue profile as described herein. For example, tissue treatmentprofiles based on axial and sagittal images as described herein.

FIG. 41 shows nozzle back pressure versus maximum depth of penetration.Maximum penetration in millimeters is shown as a function of nozzlepressure in psi for both 130 micron nozzle and 150 micron nozzle. Basedon the identified nozzle size and tissue penetration depth, the softwareor user can identify an appropriate nozzle pressure to treat thepatient.

FIG. 42 shows nozzle flow rate versus back pressure for 130 micronnozzle and 150 micron nozzle. The pressure and flow rate are shown. Fora flow rate, the flow rate is shown in milliliters per minute and thepressure is shown in psi. The flow rate can be from about 100milliliters per minute to about 250 milliliters per minute, and thepressure can be from under 1000 psi to as high as 4000 psi or, forexample, 8000 psi. In specific embodiments, the flow rate with a largerdiameter nozzle is approximately linear with the pressure and the flowrate with the 130 micron nozzle is approximately linear with pressure.These relationships of flow rate and pressure can be used toappropriately set the pressure for treatment for desired flow rate.Furthermore, these flow rate pressure relationships can be non-linearwhen the range is expanded to lower values, or higher values, or both.Alternatively or in combination, the flow rate pressure relationshipscan be non-linear when different nozzles with different characteristicsare used, for example.

A person of ordinary skill in the art can use the one or more of thenozzle pressure, cut depth and flow rates to resect tissue to apredefined profile and volume as described herein.

While a particular advantage of the present invention is thesimultaneous delivery of a pressurized fluid stream and laser or otheroptical energy, in some instances either the fluid stream or the opticalenergy may be delivered alone. For example, it may be desirable todeliver the fluid stream without optical energy to perform conventionalwater jet resection or volume reduction of tissue. After such water jettreatment, the optical energy can be added to cauterize and/or perform aprocedure at a higher total energy. Optionally, the pressure, volume,flow velocity, temperature, or other characteristics of the fluid streammay be varied depending on whether optical energy is present, e.g.,cauterization may be performed at lower pressures than tissue resection.In all cases the removed tissue and/or remaining tissue can be used forhistological evaluation or other diagnostic procedures. It is aparticular advantage that the removed tissue has not been vaporized orotherwise damaged to the extent it is with PVP and the subsequentanalysis is impaired.

Referring to FIG. 43, an exemplary prostatic tissue debulking device 10constructed in accordance with the principles of the present inventioncomprises a catheter assembly generally including a shaft 12 having adistal end 14 and a proximal end 16. The shaft 12 will typically be apolymeric extrusion including one, two, three, four, or more axiallumens extending from a hub 18 at the proximal end 16 to locations nearthe distal end 14. The shaft 12 will generally have a length in therange from 15 cm to 25 cm and a diameter in the range from 1 mm to 10mm, usually from 4 mm to 8 mm. The shaft will have sufficient columnstrength so that it may be introduced upwardly through the male urethra,as described in more detail below.

The shaft will include a fluid/coherent light energy source 20positioned near the distal end 14 of the shaft 12. The source 20, inturn, is connected to an external light source 22 and light transmissivefluid source 28. Distal to the energy source 20, an inflatable anchoringballoon 24 will be positioned at or very close to the distal end 14 ofthe shaft. The balloon will be connected through one of the axial lumensto a balloon inflation source 26 connected through the hub 18. Inaddition to the light source 22, fluid pump 28, and balloon inflationsource 26, the hub will optionally further include connections for anaspiration (a vacuum) source 30, and/or an insufflation (pressurized CO2or other gas) source 32. In the exemplary embodiment, the fluid pump 28can be connected through an axial lumen (not shown) to one or moreport(s) 34 on an inner fluid delivery tube 35. The aspiration source 30can be connected to a window or opening 38, usually positionedproximally of the energy source 20, while the insufflation source 32 canbe connected to a port 36 formed in the wall of shaft 12. The energywill be directed through the window 38 as described in more detailbelow.

Referring now to FIGS. 44A-44E, a device 60 constructed in accordancewith the principles of the present invention comprises a central shaft62 having a window 64 near a distal end thereof. A hypotube 66 iscarried in a proximal bushing 68 (FIG. 44A) and a threaded region 70 ofthe hypotube 66 is received within internal threads of the bushing 68.Thus, rotation of the hypotube can axially advance and retract thehypotube relative to the bushing and central shaft 62. Typically,rotation and axial movement of the hypotube 66 relative to the bushing68 and central shaft 62 is achieved by separately controlling the axialand rotational movement of the hypotube, thereby obviating the need forinternal threads and allowing for more versatility of movement withinthe window 64.

The hypotube 66 carries a laser fiber 72 and includes a lumen 74 whichcan receive and deliver a water or other fluid jet as will be describedin more detail below. The central shaft 62 further includes a ballooninflation lumen 76 and lumen 78 for the suction removal of ablatedtissue.

When introduced through the urethra, the device 60 will typically becovered by a sheath 80 as illustrated in FIG. 44D (only a portion of thesheath 80 is shown in FIG. 44A). When fully covered with sheath 80, thewindow 66 is protected so that it reduces scraping and injury to theurethra as the device is advanced.

Once in place, the sheath 80 will be retracted, exposing the window, asillustrated in FIG. 44E. The hypotube 66 may then be rotated andadvanced and/or retracted so that the fluid stream FS which carries theoptical energy may be delivered through the delivery port 82.Additionally, a balloon 84 may be inflated in order to anchor the device60 within the bladder as previously described.

As illustrated in FIG. 45, a scalpel-type device 180 may be attached toa programmable machine arm 182 so that the systems can be used inrobotic or other automatic, programmable systems. The programmablemachine arm 182 may be suspended over tissue T to be treated, and thewater jet or other pressurized fluid stream FS carrying the coherentlight is used to cut or incise the tissue, as illustrated. Theprogrammable machine arm may be moved in any of the X, Y, and/or Zdirections, where the control is provided by computer or by a manualcontrol system, for example, guided by a joystick or other manipulator.

A system 200 for the automatic deployment of the light fluid deliverydevice 60 of FIGS. 44A-44E is illustrated in FIG. 46. The central shaft62, hypotube 66, and sheath 80 of the device are connected to a controlshaft 202 which in turn is connected to a base unit 204 which includesmotors and control circuitry (not shown) for controlling the relativemovements of the shaft, hypotube, and sheath. The base unit 204 in turnwill be connected to a pressurized fluid source 210, a laser or otheroptical energy source 212, and an external console or controller 214which provides an interface for programming and/or manipulating thedevice 60. In addition to the device 60, the system 200 may include anexternal anchor frame 230 which can be automatically (or manually)advanced and retracted coaxially over the device 60. The anchor frame230 typically includes an atraumatic ring 232 for engaging and anchoringthe system against tissue after the device has been introduced and theballoon expanded to allow the device to be tensioned.

As shown in FIG. 47, a handheld device 100 may comprise a shaft 102having a distal end with a nozzle 104 oriented to deliver a pressurizedfluid in an axial stream or water jet FS. A laser fiber 106 is disposedaxially within the shaft 102 and terminates in a lens 108 which focuseslight into the axial water jet FS. Water or other fluid is deliveredunder pressure in an annular region 110 of the shaft 102 which surroundsthe laser fiber 106 and is enclosed by an outer perimeter of the shaft.The handheld device 100 is capable of delivering an axial water jet orother pressurized fluid stream and is useful for the manual cutting oftissue or bone, as shown in FIG. 48. The handheld device 100 isconnected to a pressurized fluid source 120, a light source 122, andcontrol circuitry 124, typically by a connecting cord 126. The user canthus control the fluid pressure, the amount of light energy beingintroduced into the fluid stream, movement of the nozzle (velocity,direction, limits, etc.) and other aspects of the treatment protocol inaddition to the axial and rotational movement parameters using thecontrol circuitry. Optionally, although not illustrated, the nozzle 104will be adjustable in order to adjust the width and focus of the fluidstream FS in order to allow further flexibility for the treatment. Whenused for cutting tissue, it can be manipulated much as a scalpel.

Thus, in a first aspect of the present invention, methods for modifyingtissue comprise generating a stream of a light transmissive fluidmedium, such as saline, water, alcohol, liquefied CO₂ and otherliquefied gases (gases which are liquids at the pressure and temperatureof use), fluid containing drug compounds such as vasocontricting agents(to reduce bleeding) and/or anesthetic agents (to reduce pain) and/oranti-inflammatory agents, antibiotics (to reduce infection), or thelike. A source of coherent light, such as a laser, is coupled to thelight transmissive medium through a waveguide or other optical couplerso that light is transmitted through said stream by total internalreflection. The fluid stream which carries the coherent light is thendirected at target tissue, such as within the prostate.

While a particular advantage of the present invention is thesimultaneous delivery of a pressurized fluid stream and laser or otheroptical energy, in some instances either the fluid stream or the opticalenergy may be delivered alone. For example, it may be desirable todeliver the fluid stream without optical energy to perform conventionalwater jet resection or volume reduction of tissue. After such water jettreatment, the optical energy can be added to cauterize and/or perform aprocedure at a higher total energy. Optionally, the pressure, volume,flow velocity, temperature, or other characteristics of the fluid streammay be varied depending on whether optical energy is present, e.g.,cauterization may be performed at lower pressures than tissue resection.In all cases the removed tissue and/or remaining tissue can be used forhistological evaluation or other diagnostic procedures. It is aparticular advantage that the removed tissue has not been vaporized orotherwise damaged to the extent it is with PVP and the subsequentanalysis is impaired.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will be apparent to those skilledin the art without departing from the scope of the present disclosure.It should be understood that various alternatives to the embodiments ofthe present disclosure described herein may be employed withoutdeparting from the scope of the present invention. Therefore, the scopeof the present invention shall be defined solely by the scope of theappended claims and the equivalents thereof

1. A medical method, comprising: providing a water jet system, whereinthe water jet system comprises a water jet fluid flush tube and anaspiration tube; endoscopically inserting the water jet system into apatient; utilizing an ultrasound system to provide an image of the waterjet system relative to the patient; applying fluid from the water jetflush tube to create a cutting jet area to break apart tissue, thecutting jet area being controlled based at least in part on a flow ratemeter; robotically controlling cutting motion by the water jet fluidflush tube to break apart the tissue; and using the aspiration tube toremove the broken apart tissue via aspiration.
 2. The medical method ofclaim 1, further comprising attaching the water jet system to an arm. 3.The medical method of claim 2, wherein the arm is a robotic arm, andwherein the robotic arm is coupled to the water jet system via aninstrument driver.
 4. The medical method of claim 1, wherein the fluidcomprises a saline solution.
 5. The medical method of claim 1, whereinthe water jet system comprises a central processing unit for controllingthe aspiration tube.
 6. The medical method of claim 1, wherein theapplying fluid includes modulating the flow.
 7. The medical method ofclaim 1, wherein a portion of the water jet fluid flush tube and aportion of the aspiration tube are co-axially disposed relative to oneanother.
 8. The medical method of claim 1, wherein the cutting motionincludes a predefined shape.
 9. The medical method of claim 1, furthercomprising controlling, based on feedback, a flow characteristic of thewater jet flush tube to treat the tissue to be broken apart.
 10. Amedical method, comprising: providing a water jet system, wherein thewater jet system comprises a water jet fluid flush tube and anaspiration tube; endoscopically inserting the water jet system into apatient; utilizing an ultrasound system to provide an image of the waterjet system relative to the patient; applying fluid from the water jetflush tube to create a cutting jet area to break apart tissue, thecutting jet area being controlled based at least in part on a flow ratemeter; robotically controlling cutting motion by the water jet fluidflush tube to break apart the tissue; controlling, based on feedback, aflow characteristic of the water jet flush tube to treat the tissue tobe broken apart; and using the aspiration tube to remove the brokenapart tissue via aspiration.
 11. The medical method of claim 10, furthercomprising attaching the water jet system to an arm.
 12. The medicalmethod of claim 11, wherein the arm is a robotic arm, and wherein therobotic arm is coupled to the water jet system via an instrument driver.13. The medical method of claim 10, wherein the fluid comprises a salinesolution.
 14. The medical method of claim 10, wherein the water jetsystem comprises a central processing unit for controlling theaspiration tube.
 15. The medical method of claim 10, wherein theapplying fluid includes modulating the flow.
 16. The medical method ofclaim 10, wherein a portion of the water jet fluid flush tube and aportion of the aspiration tube are co-axially disposed relative to oneanother.
 17. The medical method of claim 10, wherein the cutting motionincludes a predefined shape.